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Careers for Researchers Beyond Academia

Posted in Scientist: Career considerations, tagged American Journal of Human Genetics, National Institutes of Health on January 30, 2013| 1 Comment »

Reporter: Aviva Lev-Ari, PhD, RN

 

“Scientist: Career considerations” Research Category on this Open Access Online Scientific Journal, includes the following articles:

AAAS February 14-18, 2013, Boston: Symposia Cultivating the Science and Scientists for 21st Century Drug Discovery and Development

http://pharmaceuticalintelligence.com/?s=AAAS

Picturing US-Trained PhDs’ Paths and Pharmaceutical Industry’s Crisis of Productivity: Partnerships between Industry and Academia

http://pharmaceuticalintelligence.com/2012/06/27/picturing-us-trained-phds-paths-pharmaceutical-industrys-crisis-of-productivity-partnerships-between-industry-and-academia/

BEYOND THE “MALE MODEL”: AN ALTERNATIVE FEMALE MODEL OF SCIENCE, TECHNOLOGY AND INNOVATION

http://pharmaceuticalintelligence.com/2012/08/01/beyond-the-male-model-an-alternative-female-model-of-science-technology-and-innovation/

Introducing Career Streams into Academic Research

http://pharmaceuticalintelligence.com/2012/08/01/introducing-career-streams-into-academic-research/

GenomeWeb Feature: Careers for Researchers Beyond Academia

January 30, 2013

By Ciara Curtin

NEW YORK (GenomeWeb News) – There comes a time for many researchers — and it can be during graduate school, while a postdoc, or even later in their careers — when they realize that academia is not quite for them. It might be because they have a broad interest in science that they want to embrace or because competing for increasingly smaller slices of the grant pie has become wearisome.

According to a report put together by the Biomedical Research Workforce Working Group at the National Institutes of Health last June, fewer than half of the biomedical PhDs who trained in the US enter academia. Much of the other 57 percent still work, though, in science or science-related fields. About 30 percent of US-trained PhDs work in industry, both in research and non-research capacities, and, while about 18 percent of US-trained PhDs are no longer researchers, many of them have jobs where such a background is necessary.

“There are a lot of different ways to be successful,” Sara Cullinan, the deputy editor of the American Journal of Human Genetics, said. “If you are not happy running a research program, you are not going to be successful, so you should find something that will make you happy.”

There are a number of career options for PhD scientists, even outside of academia — industry, academic journals, patent law, or government could all beckon, among scores of others. While people working in these fields apply their scientific background in different ways, certain traits are common, including being able to work in teams as well as having good communication skills, and, of course, it helps to be highly motivated.

Industrial Approach

Many researchers looking to move on from academia turn to see what industry has to offer. Tina Hambuch, a staff scientist at Illumina who directs their professional service group, said she was not necessarily looking to leave academia, she was just curious about the opportunities in industry.

“It wasn’t something that I was planning on, leaving academia, but I certainly recognized that there weren’t necessarily the kinds of opportunities to be successful in academia that would allow everybody to stay in it,” she said. “And there definitely were also some things about academia that were less attractive to me. Industry offered some opportunities to … work in a more collaborative, team-oriented environment, rather than having to be on your own, running a lab, getting your grants, all by yourself.”
To make the switch, she said she searched for companies that were in line with her focus, finding positions first at Ambry Genetics and then at Illumina. Hambuch added that her manager helped ease her transition by clearly laying out what was expected of her and where she fit into the company. Paul Bianchi, the senior vice president of human resources at Illumina, adds that the company offers an orientation process to acclimate new hires to company life and their place in it.

Life in industry, Hambuch said, has many parallels to life in academia. There is a process to develop projects that she said is strikingly like applying for a grant; it just goes by a different name, in this case, project development process. “I’d say the biggest difference in terms of what my normal day looks like is that I have lot more interaction with other people these days,” she said.

And because of that, she added, communication skills are important for people looking to work in industry, as is being able to see the big picture. Additionally, she said, being motivated and “being able to actually take a project from start to finish — ‘finish’ can look a little different in industry than it does in academia, but there still is a finish and it is defined and so being able to get to that point is important.”

Marshaling Manuscripts

Another place to which PhD scientists head, to put their scientific skills to use outside of research, is to a journal.

Cullinan, from AJHG, recalled reading once in Science about alternative careers as a journal editor, and it just stuck in her head, even as she pursued a postdoc. “Instead of narrowing my interests onto one thing that I thought I was going to develop a research program on, I actually became even more interested in everything,” she said of her postdoc time.

Cullinan was doing her postdoc in Boston, where Cell Press and a Nature editorial office are located, and she kept a look out for any openings there. She adds that she didn’t know too much about being a journal editor when she did interview for a position, though she had spoken to a few editors at meetings. Nevertheless, she said she felt confident it was a job she could do and would like.

“The idea that someone would pay me to sit around and think about science and not do it was kind of cool,” she said.

And most of her day is now spent thinking about science. Cullinan reads and evaluates manuscripts as they come in, determining if they are a good fit with her journal and whether or not they should go out for peer review. If the manuscript is going to go out for review, she finds reviewers and organizes that process.

“At some point, you make a decision, and if [the manuscript] is going to be revised, you tell the authors: here are the reviewer’s comments, here are also things that I would like you to do or things that production would like you to do, ” she said. “And then you wait and sometime later the manuscript comes back and although you may remember it, you have to re-read it again, probably a couple of times, to see what they’ve done, and maybe it needs to be reviewed again.”

With so many moving parts, organization and time management are key skills for journal editors to have, she said, adding that the day can quickly become long if the editor isn’t focused.

At the same time, being able to communicate well is also important. “I don’t think you have to be an extrovert, but you do have to able to speak with and enjoy speaking with other people,” Cullinan said, adding that “in addition to the day-to-day email and phone calls with authors and reviewers, we do go to meetings, and you are there not only to learn about the science, but to represent the journal.”

The Legal Path

After a little more schooling, researchers with PhDs could go into patent law.

When Janis Fraser, now a principal attorney at Fish & Richardson in Boston, was working on her dissertation, she realized that she liked doing the literature research and writing about the science. Later, a friend suggested that she might be interested in patent law, which she then pursued.

“I get to use my science every day, and I am still a science geek — it’s still my soul — but I am not hunched over a bench dripping things into tubes and having experiments sometimes work and sometimes not work,” Fraser said. “Instead, I get to learn about the science, which is really the exciting thing for me.”

But to be an attorney, law school is a must. David Lu, who has a PhD, is taking the technology specialist path. By day, he works at Lando & Anastasi, also a Boston law firm, helping to draft patent applications. At night, though, he attends law school classes. This way, the firms have attorneys with backgrounds in science and the scientists become trained in the law.

“It’s a horrible amount of work,” adds Fraser, who went to law school full-time, adding that it is “a very attractive route to someone who has the stomach for all that work.” But, she adds, people who have already taken seven or so years to receive their PhD may not want to put off a career, and a salary, for another three years.

Patent attorneys early in their careers, like Lu, draft patent applications as well as responses to the United States Patent and Trademark Office and possibly even foreign patent offices. He works with clients in the personalized medicine and genomics areas. “The learning curve at the beginning is really steep, so you have to learn a lot of things very quickly,” he said.

Fraser, who is further along in her career, oversees newer attorneys who draft patent applications, advises clients, and argues with the patent office.

“Once the patent office gets hold of [the application] and comes back with this rejection, saying, ‘Here’s why your invention isn’t patentable,’ and gives all the reasons, then that’s the real challenge,” Fraser said.

Her role then is to convince the patent examiner that the invention is patentable. “So there’s delving into the scientific literature to find factual evidence that shows that the examiners’ assumptions are wrong and using legal arguments to say the examiner is misinterpreting the law and should be applying the law in this way instead of that way,” she added. “That’s a lot of fun and a big challenge, too.”

As patent lawyers spend a lot of time drafting applications and responses as well as working with clients, being a good writer and having good interpersonal skills is important, both Fraser and Lu said.

“You don’t have to know anything about law before you get started — you get trained in the law — but you do have to already come to it as an excellent writer and have a deep understanding of science and scientific principles and logic,” Fraser said. “You have to be able to craft persuasive arguments that go from A to B to C to D in logical way, inexorably leading the reader to the conclusion you want them to come to.”

Directing Funding

Researchers who are a little further along in their careers could consider becoming a program director at a funding agency. At the US National Science Foundation, most program directors have spent about six years running their own research program, though there are other positions at such agencies for people with different levels of experience.

Jane Silverthorne became a program director at NSF — she is now the director of the Division of Integrative Organismal Systems — after serving on a review panel, though not without a little prodding.

After the panel, that division director came up to her and said that she thought that Silverthorne would make a good program director and asked if she would be interested. “And I said what everybody always says when we ask them that, which is: ‘I’d love to, but just not right now,'” Silverthorne said.

That director then asked her the following year as well, and when Silverthorne put her off again, the director said she would continue to call her. “That’s exactly what she did, and one day I said yes,” Silverthorne added. “I came here for a year and I never left.”

Many program directors at NSF are academic researchers that are on loan from their home institution for a period of time, but others are in permanent positions. That reliance on academia and that “structure also gives NSF a unique feel from other government agencies,” noted Lily Whiteman, the senior public affairs officer at NSF.

When Silverthorne moved into a permanent position, she oversaw the plant genome research program. “I came to NSF for the opportunity to run that program and get a better sense of how NSF works,” she said. As a permanent program director she gave up the opportunity to run her own research program, “but what you get in return is the opportunity to help shape a whole field and help support other people’s research and help their programs thrive,” she added.

Panels at NSF are advisory; it’s the program director that makes funding recommendations in conjunction with the division director. “It ensures that the scientific expert is actually recommending the funding, and then the division director will look at some of the other issues along with the program director, for example, ensuring that we have a balance in the awards that we are making with regards to science and demographics and geographical area, and so on,” Silverthorne said.

As program directors work with division directors and panels, the ability to work as part of a team is an important trait for a program director to have, as is being a good listener and not being afraid to take risks.

“A very important role a program director can play is in looking at scientific opportunities and recognizing an area that is nascent, potentially transformative … and being willing to make some kind of investment in that, to give it a chance to demonstrate whether in fact it can do that,” Silverthorne added.

If leaving academia and going into a new field seems a bit daunting, keep in mind that many people in those fields have been through a similar process.

“When you are in the lab and you are having these thoughts, your colleagues are not, and so it is kind of this semi-private thing going on in your head,” AJHG’s Cullinan said. “You go and you work and, if you are some place like Nature or Science or Cell Press, everyone else that you work with went through the same thing, and you find people that you have a lot in common with even beyond the fact that you all have science training.”

Ciara Curtin is GenomeWeb’s science features editor as well as the editor of the Daily Scan and Careers blogs. E-mail Ciara Curtinand follow @DailyScan, and @CareersGW on Twitter.

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State of the art in oncologic imaging of lungs.

Posted in Biomarkers & Medical Diagnostics, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Health Economics and Outcomes Research, HealthCare IT, Imaging-based Cancer Patient Management, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Population Health Management, Genetics & Pharmaceutical, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Uncategorized, tagged American Cancer Society, Cancer - General, cancer deaths, cancer imaging, cancer mortality, Clinical trial, CT, FDA, health, lung, lung adenocarcinoma, Lung cancer, medicine, National Institutes of Health, NCI, Non-small cell lung cancer, PET, PET/CT, relative survival rate, research, science on January 23, 2013| 5 Comments »

State of the art in oncologic imaging of lungs.

Author and Curator: Dror Nir, PhD

• 

This is the second post in a series in which I will address the state of the art in oncologic imaging based on a review paper; Advances in oncologic imaging^†‡ that provides updates on the latest approaches to imaging of 5 common cancers: breast, lung, prostate, colorectal cancers, and lymphoma. This paper is published at CA Cancer J Clin 2012. © 2012 American Cancer Society.

The paper gives a fair description of the use of imaging in interventional oncology based on literature review of more than 200 peer-reviewed publications.

In this post I summaries the chapter on lung cancer imaging.

Lung Cancer Imaging

“Lung cancer remains the most common cause of death from cancer worldwide, having resulted in 1.38 million deaths (18.2% of all cancer deaths) in 2008.48 It also represents the leading cause of death in smokers and the leading cause of cancer mortality in men and women in the United States. In 2012, it was estimated that 226,160 new cases of lung cancer would be diagnosed (accounting for about 14% of cancer diagnoses) and that lung cancer would cause 160,340 deaths (about 29% of cancer deaths in men and 26% of cancer deaths in women) in the United States.1 The 1-year relative survival rate for the disease increased from 35% to 43% from 1975 through 1979 to 2003 through 2006.49 The 5-year survival rate is 53% for disease that is localized when first detected, but only 15% of lung cancers are diagnosed at this early stage.”

For cancer with such poor survival rates removal of the primary lesion by surgery at an early-stage disease is the best option. The current perception in regards to lung cancr is that patients may have subclinical disease for years before presentation. It is also known that early lung cancer lesions; adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are slow-growing, doubling time which can exceed 2 years.52 But, since at present, no lung cancer early-detection biomarker is clinically available, the diagnosis of this disease is primarily based on symptoms, and detection often occurs after curative intervention and when it’s already too late – see: Update on biomarkers for the detection of lung cancer and also Diagnosing lung cancer in exhaled breath using gold nanoparticles. Until biomarker is found, the burden of screening for this disease is on imaging.

“AIS and MIA generally appear as a single peripheral ground-glass nodule on CT. A small solid component may be present if areas of alveolar collapse or fibroblastic proliferation are present,50, 51 but any solid component should raise concern for a more invasive lesion (Fig. 8). Growth over time on imaging can often be difficult to assess due to the long doubling time of these AIS and MIA, which can exceed 2 years.52 However, indicators other than growth, such as air bronchograms, increasing density, and pleural retraction within a ground-glass nodule are suggestive of AIS or MIA.

CT image shows a ground glass nodule, which is the typical appearance of AIS, in the right upper lobe.

 

CT (A) demonstrated extensive consolidation with air bronchograms in the left upper lobe, which at surgical resection were found to represent adenocarcinoma of mixed subtype with predominate (70%) mucinous bronchioloalveolar subtype. PET imaging in the same patient (B) demonstrated uptake in the lingula higher than expected for bronchioloalveolar carcinoma and probably due to secondary inflammation/infection. CT (C) obtained 3 years after images (A) and (B) demonstrated biopsy-proven recurrent soft-tissue mass near surgical site. Fused FDG/PET images (D) demonstrate no uptake in the area. This finding is consistent with the decreased uptake usually seen in tumors of bronchioloalveolar histology (new terminology of MIA).

In August 2011 the results of the “National Lung Screening Trial “ which was funded by the National Cancer Institute (NCI) were published in NEJM; Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. This randomized study results showed that with low-dose CT screening of high-risk persons, there was a significant reduction of 20% in the mortality rate from lung cancer as compared to chest radiographs screening.

Based on these results one can find the following information regarding Lung Cancer Screening on the NCI web-site:

“Three screening tests have been studied to see if they decrease the risk of dying from lung cancer.

The following screening tests have been studied to see if they decrease the risk of dying from lung cancer:

• Chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.
• Sputum cytology: Sputum cytology is a procedure in which a sample of sputum (mucus that is coughed up from the lungs) is viewed under a microscope to check for cancer cells.
• Low-dose spiral CT scan (LDCT scan): A procedure that uses low-dose radiation to make a series of very detailed pictures of areas inside the body. It uses an x-ray machine that scans the body in a spiral path. The pictures are made by a computer linked to the x-ray machine. This procedure is also called a low-dose helical CT scan.

Screening with low-dose spiral CT scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.

A lung cancer screening trial studied people aged 55 years to 74 years who had smoked at least 1 pack of cigarettes per day for 30 years or more. Heavy smokers who had quit smoking within the past 15 years were also studied. The trial used chest x-rays or low-dose spiral CT scans (LDCT) scans to check for signs of lung cancer.

LDCT scans were better than chest x-rays at finding early-stage lung cancer. Screening with LDCT also decreased the risk of dying from lung cancer in current and former heavy smokers.

A Guide is available for patients and doctors to learn more about the benefits and harms of low-dose helical CT screening for lung cancer.

Screening with chest x-rays or sputum cytology does not decrease the risk of dying from lung cancer.

Chest x-ray and sputum cytology are two screening tests that have been used to check for signs of lung cancer. Screening with chest x-ray, sputum cytology, or both of these tests does not decrease the risk of dying from lung cancer.”

The authors of Advances in oncologic imaging^†‡ found out that for pre-treatment staging and post treatment follow-up of lung cancer patients mainly involves CT (preferably contrast enhanced, FDG PET and PET/CT. “Integrated PET/CT has been found to be more accurate than PET alone, CT alone, or visual correlation of PET and CT for staging NSCLC (Non-small-cell lung carcinoma).59 “

The standard treatment of choice for localized disease remains surgical resection with or without chemo-radiation therapy (stage dependant). “The current recommendations for routine follow-up after complete resection of NSCLC are as follows: for 2 years following surgery a contrast-enhanced chest CT scan every 4 to 6 months and then yearly non-contrast chest CT scans.62 Detection of recurrence on CT is the primary goal in the initial years, and therefore, optimally, a contrast-enhanced scan should be obtained to evaluate the mediastinum. In subsequent years, when identifying an early second primary lung cancer becomes of more clinical importance, a non-contrast CT chest scan suffices to evaluate the lung parenchyma.

CT (A) of 78-year-old male who was status post–left lobe lobectomy and left upper lobe wedge resection shows recurrent nodule at the surgical resection site. Fused PET/CT (B) demonstrates increased [18F]FDG uptake in the corresponding nodule at the surgical resection site consistent with recurrent tumor.

In patients undergoing chemotherapies: “ [¹⁸F]FDG PET response correlates with histologic response.63 [¹⁸F]FDG PET scan data can provide an early readout of response to chemotherapy in patients with advanced-stage lung cancer.64

In patients treated by recently developed “Targeted Therapies” such as Radiofrequency ablation (RFA) the authors found out that PET/CT is the preferred imaging modality for post treatment follow-up.

“ Most patients treated with pulmonary ablation will have had a pre-procedure CT or a fusion PET/CT scan, which allows more precise anatomic localization of abnormalities seen on PET. Generally, either CT or PET/CT is performed within a few weeks of the procedure to provide a new baseline to which future images can be compared to assess for changes in size, degree of enhancement or [¹⁸F]FDG avidity.67”

CT (A) demonstrates new left upper lobe mass representing new primary NSCLC in a patient who had a status post–right pneumonectomy for a prior NSCLC. CT (B) obtained in the same patient 2 weeks after radiofrequency ablation (RFA) demonstrates the postablation density in the left upper lobe. Fused PET/CT (C) obtained 4 months after RFA demonstrates mild [18F]FDG uptake at RFA site in the left upper lobe consistent with posttreatment inflammation. Fused PET/CT (D) obtained 7 months after RFA demonstrates new focal [18F]FDG uptake at post-RFA-opacity consistent with recurrent tumor.

Prostate Cancer Imaging

To be followed…

Other research papers related to the management of Lung cancer were published on this Scientific Web site:

Diagnosing lung cancer in exhaled breath using gold nanoparticles

Lung Cancer (NSCLC), drug administration and nanotechnology

Non-small Cell Lung Cancer drugs – where does the Future lie?

Comprehensive Genomic Characterization of Squamous Cell Lung Cancers

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State of the art in oncologic imaging of breast.

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, CANCER BIOLOGY & Innovations in Cancer Therapy, Computational Biology/Systems and Bioinformatics, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Health Economics and Outcomes Research, HealthCare IT, Imaging-based Cancer Patient Management, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Nanotechnology for Drug Delivery, Personalized and Precision Medicine & Genomic Research, Population Health Management, Genetics & Pharmaceutical, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Reproductive Biology & Bio Instrumentation, Technology Transfer: Biotech and Pharmaceutical, tagged American Society of Clinical Oncology, Biology, breast cancer, Cancer - General, Clinical trial, Conditions and Diseases, FDA, FDG PET, Food and Drug Administration, health, medicine, MRI, National Institutes of Health, oncologic imaging, oncology, PEM, Personalized medicine, PET/MRI, Proceedings of the National Academy of Sciences of the United States of America, research, United States on January 21, 2013| 2 Comments »

State of the art in oncologic imaging of breast.

Author-Writer: Dror Nir, PhD

Word Cloud By Danielle Smolyar

In the coming posts I will address the state of the art in oncologic imaging based on a review paper; Advances in oncologic imaging^†‡ that provides updates on the latest approaches to imaging of 5 common cancers: breast, lung, prostate, colorectal cancers, and lymphoma. This paper is published at CA Cancer J Clin 2012. © 2012 American Cancer Society.

The paper gives a fair description of the use of imaging in interventional oncology based on literature review of more than 200 peer-reviewed publications.

In this post I summaries the chapter on breast cancer imaging.

Breast Cancer Imaging

As a start the authors describes the evolution in the ACS imaging guidelines for breast cancer screening. Most interesting to learn is how age limits are changing. The most recent: “In 2010, the Society of Breast Imaging and the Breast Imaging Commission of the ACS issued recommendations for breast cancer screening to provide guidance in light of the controversies and emerging technologies.5 These recommendations were based on multiple prospective randomized trials as well as population-based experience.

Recommendations for screening with non-mammographic imaging are based not on evidence showing mortality reduction but largely on surrogate indicators, i.e., tumor size and nodal status, suggesting improved survival compared with women who are not screened.” I have referred to these guidelines in my recent post: Not applying evidence-based medicine drives up the costs of screening for breast-cancer in the USA.

As long as imaging interpretation is based mainly on observations related to lesion morphology:

“The imaging characteristics of malignant lesions are nonspecific and usually do not allow a definitive diagnosis. When a biopsy is recommended based on mammography, it has a 25% to 45% likelihood of resulting in a diagnosis of carcinoma.11 Similar positive predictive values are reported for biopsies recommended based on MRI.”

It is worthwhile noting that these results do not reflect purely the specificity of the imaging device but rather the specificity of the whole workflow; i.e imaging, biopsy and histopathology. All imaging techniques have false negatives: Mammography screening of general population misses approximately 20% of the cancers. This rate increases as breast density increases. MRI is not applied to general population. When applied to highly suspicious cases MRI misses ~10% of the invasive cancers. Although ultrasound has proven to be useful in detecting cancer especially in women with dense breasts: Automated Breast Ultrasound System (‘ABUS’) for full breast scanning: The beginning of structuring a solution for an acute need! Based on the literature reviewed by the authors of this paper they do not recommend routine sonography for these women.

For women with locally advanced breast cancer (Fig. 2) who undergo neoadjuvant therapy before breast surgery, the authors recommends post-treatment staging using MRI, which has been found to predict complete response with sensitivity above 60% and specificity as high as 90%.26

A 27-year-old female with locally advanced poorly differentiated invasive ductal carcinoma underwent evaluation of extent of disease before starting neoadjuvant chemotherapy. Sagittal fat-suppressed T1-weighted postcontrast MR images demonstrate an almost 6-cm heterogeneously enhancing mass (A) involving the skin of the lower breast (arrow) with (B) right axillary (arrow) and (C) right internal mammary adenopathy (arrow).

Same is recommended for women who have undergone lumpectomy if the surgical margins are positive. As post therapy follow-up, a new baseline mammogram of the treated breast is recommended followed by annual mammography.

In regards to emerging technology the following are discussed: Mammographic tomosynthesis – see also Improving Mammography-based imaging for better treatment planning

Contrast-enhanced digital mammography – “involves the injection of iodinated contrast material, as is done for computed tomography (CT); this enables hypervascular lesions to be seen with modified mammography technology, potentially providing the same information obtained through MRI. Little has been published on the clinical application of this technology, but diagnostic accuracy better than that of mammography and approaching that of MRI has been reported.31, 32”

MR choline spectroscopy – has been shown to improve the positive predictive value of breast MRI and may be useful in reducing the number of lesions that require biopsy (Fig. 4).33 Studies of spectroscopy have reported sensitivities of 70% to 100% and specificities of 67% to 100% in the detection of breast cancer. Decreasing choline concentrations may also be a useful indication of tumor response to treatment before any change in tumor volume can be detected.34, 35 Technical factors have limited the use of spectroscopy to lesions 1 cm in size or larger.”

Sagittal fat-suppressed T1-weighted postcontrast MR image is shown (A) of the right breast of a 48-year-old female who was status post–contralateral mastectomy for DCIS with the spectroscopy voxel placed over an enhancing mass (arrow). The magnified spectrum (B) demonstrated no choline peak. Biopsy yielded fibroadenoma.

Diffusion-weighted MRI (DW-MRI) – “adding DW-MRI data to other imaging characteristics of lesions on breast MRI may increase the positive predictive value of the examination, in turn decreasing the number of benign lesions requiring biopsy for diagnosis.” See also Imaging: seeing or imagining? (Part 2).

Axial T1-weighted fat-suppressed postcontrast MR image is shown (A) of the left breast of a 42-year-old female with biopsy-proven contralateral cancer undergoing evaluation of disease extent. An enhancing mass (arrow) was seen in the left breast. This mass (arrow) was also demonstrated on the axial diffusion-weighted MR image (B). Biopsy yielded fibroadenoma with atypical ductal hyperplasia and lobular carcinoma in situ.

Ultrasound-elastography – “Ultrasound elastography has been reported to differentiate benign from malignant breast lesions with sensitivities of 78% to 100% and specificities of 21% to 98%.39 When added to other US techniques, it may improve radiologists’ performance in distinguishing malignant breast lesions.”

Positron emission tomography (PET) – “alone or combined with CT, allows noninvasive, quantitative assessment of biochemical and functional processes at the molecular level in the body. It is most often performed with the radiolabeled glucose analogue [18F] fluorodeoxyglucose ([18F]FDG) to detect the elevated glucose metabolism that is a hallmark of cancer. In breast cancer, its utility depends on the pretest probability for advanced disease, and thus the clinical stage.” The authors found that the use of [18F] FDG PET to patients with stage I and II disease is “limited”. Specifically, they claim that it is not sufficiently accurate for axillary nodal staging in this subset of patients.40 The did find enough evidence to recommend the use of FDG PET in patients with advanced disease: “where it accurately defines disease extent,41 and frequently eliminates the need for other imaging tests, and provides an early readout of treatment response as well as prognostic information.”

Combined PET/MRI is mentioned as a promising technology for predicting response to therapy “but this remains to be proven”.

Positron emission mammography (PEM) – “adapts full-body PET imaging to the breast. In a multicenter study, the interpretation of PEM in conjunction with mammographic and clinical findings yielded a sensitivity of 91% and a specificity of 93% for breast cancer.47 “. However, the authors mention that its use for screening (applying to healthy women) has been criticized because of the need to administer a radioactive tracer.

Lung Cancer Imaging

To be followed…

Other research papers related to the management of breast cancer were published on this Scientific Web site:

The unfortunate ending of the Tower of Babel construction project and its effect on modern imaging-based cancer patients’ management

 Automated Breast Ultrasound System (‘ABUS’) for full breast scanning: The beginning of structuring a solution for an acute need!

Introducing smart-imaging into radiologists’ daily practice.

Will Bio-Tech make Medical Imaging redundant?

Improving Mammography-based imaging for better treatment planning

Not applying evidence-based medicine drives up the costs of screening for breast-cancer in the USA.

New Imaging device bears a promise for better quality control of breast-cancer lumpectomies – considering the cost impact

Harnessing Personalized Medicine for Cancer Management, Prospects of Prevention and Cure: Opinions of Cancer Scientific Leaders @ http://pharmaceuticalintelligence.com

Predicting Tumor Response, Progression, and Time to Recurrence

“The Molecular pathology of Breast Cancer Progression”

Personalized medicine gearing up to tackle cancer

Whole-body imaging as cancer screening tool; answering an unmet clinical need?

What could transform an underdog into a winner?

Mechanism involved in Breast Cancer Cell Growth: Function in Early Detection & Treatment

Nanotech Therapy for Breast Cancer

A Strategy to Handle the Most Aggressive Breast Cancer: Triple-negative Tumors

Optical Coherent Tomography – emerging technology in cancer patient management

Breakthrough Technique Images Breast Tumors in 3-D With Great Clarity, Reduced Radiation

Closing the Mammography gap

Imaging: seeing or imagining? (Part 1)

Imaging: seeing or imagining? (Part 2)

 

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Improving Mammography-based imaging for better treatment planning

Posted in Health Economics and Outcomes Research, HealthCare IT, Imaging-based Cancer Patient Management, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Personalized and Precision Medicine & Genomic Research, Uncategorized, tagged Clinical trial, Food and Drug Administration, National Institutes of Health, Personalized medicine, tomosynthesis on January 14, 2013| 6 Comments »

Improving Mammography-based imaging for better treatment planning

Author and Curator: Dror Nir, PhD

• 

Many of the comments made on my last posts: New Imaging device bears a promise for better quality control of breast-cancer lumpectomies – considering the cost impact , Not applying evidence-based medicine drives up the costs of screening for breast-cancer in the USA, Optical Coherent Tomography – emerging technology in cancer patient management

Were related to the benefit of better planning lumpectomies based on priory knowledge of the lesions’ size and location. The main challenge in using imaging as a tool for treatment planning is the devices’ specificity; i.e. the probability of identifying healthy tissue as malignant. The reason is the wish to avoid unnecessarily large excisions. When discussing the use of “popular” non-ionizing devises such as MRI in breast-imaging; e.g. my post introducing smart-imaging into radiologists’ daily practice I mentioned the low specificity of MRI in that respect. So, if one is reluctant to use ultrasound, for example due to its large inter observer variability and want to rely on the Mammography based work-flow, what new modalities are available?

Stereoscopic digital mammography

Stereoscopic digital mammography (SDM) uses a pair of digital mammograms, taken from slightly different angles and a stereo display workstation loaded with image-analysis software, to create a three-dimensional image of the internal structure of each breast. The resulting stereo image reveals more detail within the breast tissue than a standard two-dimensional mammogram.

Radiologist interacting with a stereo digital mammography workstation. (Credit: Image courtesy of Radiological Society of North America)

Recently published materials:

Abstract

Stereoscopic Digital Mammography: Improved Specificity and Reduced Rate of Recall in a Prospective Clinical Trial

Carl J. D’Orsi, MD, David J. Getty, PhD, Ioannis Sechopoulos, PhD, Mary S. Newell, MD, Kathleen R. Gundry, MD, Sandra R. Bates, MD, Robert M. Nishikawa, PhD, Edward A. Sickles, MD, Andrew Karellas, PhD and Ellen M. D’Orsi, RT(R)(M)

Purpose: To compare stereoscopic digital mammography (DM) with standard DM for the rate of patient recall and the detection of cancer in a screening population at elevated risk for breast cancer.

 Materials and Methods: Starting in September 2004 and ending in December 2007, this prospective HIPAA-compliant, institutional review board–approved screening trial, with written informed consent, recruited female patients at elevated risk for breast cancer (eg, personal history of breast cancer or breast cancer in a close relative). A total of 1298 examinations from 779 patients (mean age, 58.6 years; range, 32–91 years) comprised the analyzable data set. A paired study design was used, with each enrolled patient serving as her own control. Patients underwent both DM and stereoscopic DM examinations in a single visit, findings of which were interpreted independently by two experienced radiologists, each using a Breast Imaging Reporting and Data System (BI-RADS) assessment (BI-RADS category 0, 1, or 2). All patients determined to have one or more findings with either or both modalities were recalled for standard diagnostic evaluation. The results of 1-year follow-up or biopsy were used to determine case truth.

 Results: Compared with DM, stereoscopic DM showed significantly higher specificity (91.2% [1167 of 1279] vs 87.8% [1123 of 1279]; P = .0024) and accuracy (90.9% [1180 of 1298] vs 87.4% [1135 of 1298]; P = .0023) for detection of cancer. Sensitivity for detection of cancer was not significantly different for stereoscopic DM (68.4% [13 of 19]) compared with DM (63.2% [12 of 19], P .99). The recall rate for stereoscopic DM was 9.6% (125 of 1298) and that for DM was 12.9% (168 of 1298) (P = .0018).

Conclusion: Compared with DM, stereoscopic DM significantly improved specificity for detection of cancer, while maintaining comparable sensitivity. The recall rate was significantly reduced with stereoscopic DM compared with DM.

 

Digital Breast Tomosynthesis

Digital Breast Tomosynthesis (DBT) entered the Breast-Imaging field few years ago. Early 2011, a digital mammography device by Hologic aimed at improving the specificity of mammography was approved by the FDA as a tool that may improve cancer detection while reducing the number of patient recalls.

The DBT device takes 15 successive images, each at a slightly different angle along an arc across the breast. The concept is simple: What is hidden behind fibroglandular tissue in one image might be visible in another if the angle is slightly different (Figure bellow).

Figure. (a) A suspicious lesion seen on standard 2D digital mammography (far left). (b) After examining multiple slices generated using breast tomosynthesis (5 images), the lesion seen on 2D (far left) is determined to be a false positive. (Images courtesy of Hologic. Used with permission.)

Out of recent publications related to the incorporation of DBT in breast-cancer management I picked up the following two:

Abstract

Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program

Per Skaane, MD, PhD, Andriy I. Bandos, PhD, Randi Gullien, RT, Ellen B. Eben, MD, Ulrika Ekseth, MD, Unni Haakenaasen, MD, Mina Izadi, MD, Ingvild N. Jebsen, MD, Gunnar Jahr, MD, Mona Krager, MD, Loren T. Niklason, PhD, Solveig Hofvind, PhD and David Gur, ScD

 

Purpose: To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis in a large prospective screening trial.

 Materials and Methods: A prospective, reader- and modality-balanced screening study of participants undergoing combined mammography plus tomosynthesis, the results of which were read independently by four different radiologists, is under way. The study was approved by a regional ethics committee, and all participants provided written informed consent. The authors performed a preplanned interim analysis of results from 12631 examinations interpreted by using mammography alone and mammography plus tomosynthesis from November 22, 2010, to December 31, 2011. Analyses were based on marginal log-linear models for binary data, accounting for correlated interpretations and adjusting for reader-specific performance levels by using a two-sided significance level of .0294.

 Results: Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (27% increase, adjusted for reader; P = .001). False-positive rates before arbitration were 61.1 per 1000 examinations with mammography alone and 53.1 per 1000 examinations with mammography plus tomosynthesis (15% decrease, adjusted for reader; P < .001). After arbitration, positive predictive values for recalled patients with cancers verified later were comparable (29.1% and 28.5%, respectively, with mammography alone and mammography plus tomosynthesis; P = .72). Twenty-five additional invasive cancers were detected with mammography plus tomosynthesis (40% increase, adjusted for reader; P < .001). The mean interpretation time was 45 seconds for mammography alone and 91 seconds for mammography plus tomosynthesis (P < .001).

 Conclusion: The use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.

©RSNA, 2013, Clinical trial registration no. NCT01248546

Summary of the results:

• Twenty-five additional invasive cancers were detected with mammography plus tomosynthesis — a 40% increase.
• Detection rates, including those for invasive and in situ can­cers, were 6.1 per 1,000 examinations for mammography alone and eight per 1,000 examinations for mammography plus tomosynthesis — a 27% increase.
• False-positive rates before arbitration were 61.1 per 1,000 examinations with mammography alone and 53.1 per 1,000 examinations with mammography plus tomosynthe­sis — a 15% decrease.
• After arbitration, positive predictive values for recalled patients with cancers verified later were comparable (29.1% with mammography alone and 28.5% with mam­mography plus tomosynthesis).
• Mean interpretation time was 45 seconds for mammography alone and 91 seconds for mammography plus tomosynthesis.

 

 

Abstract

Digital Breast Tomosynthesis versus Supplemental Diagnostic Mammographic Views for Evaluation of Noncalcified Breast Lesions

Margarita L. Zuley, MD, Andriy I. Bandos, PhD,  Marie A. Ganott, MD, Jules H. Sumkin, DO, Amy E. Kelly, MD, Victor J. Catullo, MD, Grace Y. Rathfon, MD, Amy H. Lu, MD and David Gur, ScD

Purpose: To compare the diagnostic performance of breast tomosynthesis versus supplemental mammography views in classification of masses, distortions, and asymmetries.

 Materials and Methods: Eight radiologists who specialized in breast imaging retrospectively reviewed 217 consecutively accrued lesions by using protocols that were HIPAA compliant and institutional review board approved in 182 patients aged 31–60 years (mean, 50 years) who underwent diagnostic mammography and tomosynthesis. The lesions in the cohort included 33% (72 of 217) cancers and 67% (145 of 217) benign lesions. Eighty-four percent (182 of 217) of the lesions were masses, 11% (25 of 217) were asymmetries, and 5% (10 of 217) were distortions that were initially detected at clinical examination in 8% (17 of 217), at mammography in 80% (173 of 217), at ultrasonography (US) in 11% (25 of 217), or at magnetic resonance imaging in 1% (2 of 217). Histopathologic examination established truth in 191 lesions, US revealed a cyst in 12 lesions, and 14 lesions had a normal follow-up. Each lesion was interpreted once with tomosynthesis and once with supplemental mammographic views; both modes included the mediolateral oblique and craniocaudal views in a fully crossed and balanced design by using a five-category Breast Imaging Reporting and Data System (BI-RADS) assessment and a probability-of-malignancy score. Differences between modes were analyzed with a generalized linear mixed model for BI-RADS–based sensitivity and specificity and with modified Obuchowski-Rockette approach for probability-of-malignancy–based area under the receiver operating characteristic (ROC) curve.

 Results: Average probability-of-malignancy–based area under the ROC curve was 0.87 for tomosynthesis versus 0.83 for supplemental views (P < .001). With tomosynthesis, the false-positive rate decreased from 85% (989 of 1160) to 74% (864 of 1160) (P < .01) for cases that were rated BI-RADS category 3 or higher and from 57% (663 of 1160) to 48% (559 of 1160) for cases rated BI-RADS category 4 or 5 (P < .01), without a meaningful change in sensitivity. With tomosynthesis, more cancers were classified as BI-RADS category 5 (39% [226 of 576] vs 33% [188 of 576]; P = .017) without a decrease in specificity.

 Conclusion: Tomosynthesis significantly improved diagnostic accuracy for noncalcified lesions compared with supplemental 

 Additional reading

Diagnostic Mammography: Identifying Minimally Acceptable Interpretive Performance Criteria

Breast Cancer: Assessing Response to Neoadjuvant Chemotherapy by Using US-guided Near-Infrared Tomography

Bilateral Contrast-enhanced Dual-Energy Digital Mammography: Feasibility and Comparison with Conventional Digital Mammography and MR Imaging in Women with Known Breast Carcinoma

Other research papers on imaging in cancer patients’ management and cancer-therapeutics were published on this Scientific Web site as follows:

 

The unfortunate ending of the Tower of Babel construction project and its effect on modern imaging-based cancer patients’ management

 

Closing the gap towards real-time, imaging-guided treatment of cancer patients.

 

The unfortunate ending of the Tower of Babel construction project and its effect on modern imaging-based cancer patients’ management

 

Closing the gap towards real-time, imaging-guided treatment of cancer patients.

 

Tumor Imaging and Targeting: Predicting Tumor Response to Treatment: Where we stand?

 

Automated Breast Ultrasound System (‘ABUS’) for full breast scanning: The beginning of structuring a solution for an acute need!

 

Introducing smart-imaging into radiologists’ daily practice.

 

Will Bio-Tech make Medical Imaging redundant?

 

Optical Coherent Tomography – emerging technology in cancer patient management

 

Personalized Pancreatic Cancer Treatment Option

 

Understand how DNA damage is repaired—knowledge that could result in the development of new and more effective drugs for cancer treatment

 

LEADERS in Genome Sequencing of Genetic Mutations for Therapeutic Drug Selection in Cancer Personalized Treatment: Part 2

 

Scientists use natural agents for prostate cancer bone metastasis treatment

 

Harnessing Personalized Medicine for Cancer Management, Prospects of Prevention and Cure: Opinions of Cancer Scientific Leaders @ http://pharmaceuticalintelligence.com

 

Predicting Tumor Response, Progression, and Time to Recurrence

 

“The Molecular pathology of Breast Cancer Progression”

 

Personalized medicine gearing up to tackle cancer

 

Whole-body imaging as cancer screening tool; answering an unmet clinical need?

 

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Reboot evidence-based medicine and reconsider the randomized, placebo-controlled clinical trial

Posted in Computational Biology/Systems and Bioinformatics, FDA Regulatory Affairs, Genome Biology, Health Economics and Outcomes Research, Health Law & Patient Safety, HealthCare IT, Medical Devices R&D Investment, Personalized and Precision Medicine & Genomic Research, Proteomics, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Statistical Methods for Research Evaluation, tagged BRAF, Clinical trial, Editor-in-chief, Eric Topol, evidence based medicine, Melanoma, National Institutes of Health, University of Antioquia on November 4, 2012| 5 Comments »

Larry H Bernstein, MD, FACP, Reporter

Clinical Trials
Dr. Eric Topol, Director of the Scripps Translational Science Institute and Editor-in-Chief of Medscape Genomic Medicine and the heart.org.
In our series The Creative Destruction of Medicine, I’m trying to get into critical aspects of how we can Schumpeter or reboot the future of healthcare by leveraging the big innovations that are occurring in the digital world, including digital medicine.

But one of the things that has been missed along the way is that how we do clinical research will be radically affected as well. We have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that’s great if one can do that, but often we’re talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials. And things are changing so fast with respect to medicine and, for example, genomically guided interventions that it’s going to become increasingly difficult to justify these very large clinical trials.

For example, there was a drug trial for melanoma and the mutation of BRAF, which is the gene that is found in about 60% of people with malignant melanoma. When that trial was done, there was a placebo control, and there was a big ethical charge asking whether it is justifiable to have a body count. This was a matched drug for the biology underpinning metastatic melanoma, which is essentially a fatal condition within 1 year, and researchers were giving some individuals a placebo.

Would we even do that kind of trial in the future when we now have such elegant matching of the biological defect and the specific drug intervention? A remarkable example of a trial of the future was announced in May.[1] For this trial, the National Institutes of Health is working with [Banner Alzheimer’s Institute] in Arizona, the University of Antioquia in Colombia, and Genentech to have a specific mutation studied in a large extended family living in the country of Colombia in South America. There is a family of 8000 individuals who have the so-called Paisa mutation, a presenilin gene mutation, which results in every member of this family developing dementia in their 40s.

Clinical Trials (journal) (Photo credit: Wikipedia)

Related articles

• Consumer-Driven Healthcare Is an Uncomfortable Concept per Eric J. Topol, MD (pharmaceuticalintelligence.com)
• Eric Topol: Information into Action at Wired Health (fora.tv)
• http://pharmaceuticalintelligence.com/2012/10/18/modernizing-drug-and-device
  -approvals-speeding-the-process/
• Qualcomm Foundation Awards Scripps Health $3.75M for Digital Health (xconomy.com)
• Scripps Physician-Scientist Dr. Eric Topol Outlines Top Five Areas for Genomic Medicine Advances in 2011 (prweb.com)

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