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Posts Tagged ‘Mayo Clinic’


 

Reporter: Prabodh Kandala, PhD

The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.

Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer.

PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests, such as computerized tomography (CT), have not shown any signs of cancer. PET imaging is not a replacement for tissue sampling and testing.

Choline C 11 Injection must be produced in a specialized facility and administered to patients shortly after its production. While PET imaging with Choline C 11 Injection has been performed at a few facilities over the past several years, none of these facilities were approved by the FDA to manufacture the agent. The Food and Drug Administration Modernization Act directed the agency to establish appropriate approval procedures and current good manufacturing practice requirements for all PET products marketed and used in the United States. The Mayo Clinic is now the first FDA-approved facility to produce Choline C 11 Injection.

“Choline C 11 Injection provides an important imaging method to help detect the location of prostate cancer in patients whose blood tests suggest recurrent cancer when other imaging tests are negative,” said Charles Ganley, M.D., director of the Office of Drug Evaluation IV in FDA’s Center for Drug Evaluation and Research. “The FDA’s approval of Choline C 11 Injection at the Mayo Clinic provides assurance to patients and health care professionals they are using a product that is safe, effective, and produced according to current good manufacturing practices.”

The safety and effectiveness of Choline C 11 Injection were verified by a systematic review of published study reports. Four independent studies examined a total of 98 patients with elevated blood PSA levels but no sign of recurrent prostate cancer on conventional imaging. After PET imaging with Choline C 11, the patients underwent tissue sampling of the abnormalities detected on the PET scans.

In each of the four studies, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas. PET scan errors also were reported. Depending on the study, falsely positive PET scans were observed in 15 percent to 47 percent of the patients. These findings underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 Injection PET scans.

Aside from an uncommon, mild skin reaction at the injection site, no side effects to Choline C 11 Injection were reported.

Choline C 11 Injection is manufactured and distributed by the Mayo Clinic PET Radiochemistry Facility in Rochester, Minn

Ref: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htm

 

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Reporter: Aviva Lev-Ari, PhD, RN

 

 

HOSTS

  • Speaker - Gianrico Farrugia, M.D.

    GIANRICO FARRUGIA, M.D.HOST

    Director, Center for Individualized Medicine, Mayo Clinic

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  • Speaker - Michael P. Snyder, Ph.D.

    CECI CONNOLLYMODERATOR

    Managing Director, Health Research Institute, PwC

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  • Speaker - Ira Flatow

    IRA FLATOWMODERATOR

    Host, “Science Friday,” National Public Radio

    FOLLOW ME ON TWITTER

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THEME 1: INDIVIDUALIZING MEDICINE TODAY: A PRIMER ON INDIVIDUALIZED MEDICINE

THEME 2: INDIVIDUALIZING CLINICAL CARE

  • Speaker - Marc S. Williams, M.D.

    MARC S. WILLIAMS, M.D.OPENING SPEAKER

    Director, Genomic Medicine Institute, Geisinger Health System

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  • Speaker - Noralane M. Lindor, M.D.

    NORALANE M. LINDOR, M.D.

    Consultant, Department of Health Sciences Research, Mayo Clinic

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  • Speaker - Yves A. Lussier, M.D.

    YVES A. LUSSIER, M.D.

    Clinical Research Information Officer and Assistant Vice President for Health Affairs, University of Illinois Hospital & Health Sciences System

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THEME 3: INDIVIDUALIZING LABORATORY MEDICINE

  • Speaker - James L. Weber, Ph.D.

    JAMES L. WEBER, PH.D.OPENING SPEAKER

    President and Founder, PreventionGenetics

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  • Speaker - John Logan Black, M.D.

    JOHN LOGAN BLACK, M.D.

    Consultant, Department of Laboratory Medicine and Pathology, Mayo Clinic

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  • Speaker - Anna Wedell, M.D., Ph.D.

    ANNA WEDELL, M.D., PH.D.

    Professor and Senior Consultant, Clinical Genetics, Centre for Inherited Metabolic Diseases, Karolinska Institutet and Karolinska University Hospital

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THEME 4: ETHICAL AND REGULATORY IMPLICATIONS OF INDIVIDUALIZING MEDICINE

  • Speaker - Henry (Hank) T. Greely, J.D.

    HENRY (HANK) T. GREELY, J.D.OPENING SPEAKER

    Director, Center for Law and the Biosciences, Stanford University

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  • Speaker - Karen J. Maschke, Ph.D.

    KAREN J. MASCHKE, PH.D.

    Research Scholar, The Hastings Center

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  • Speaker - Susan M. Wolf, J.D.

    SUSAN M. WOLF, J.D.

    McKnight Presidential Professor of Law, Medicine & Public Policy and Faegre Baker Daniels Professor of Law, University of Minnesota

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THEME 5: DECISION-SUPPORT INFRASTRUCTURE FOR INDIVIDUALIZING MEDICINE

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Curated by: Dr. Venkat S. Karra, Ph.D.

In our recent article we mentioned about the amyloidosis, most importantly the most common form of amlyodosis – Primary Amyloidosis (AL).

Primary amyloidosis (AL) is an acquired plasma cell disorder in which a monoclonal immunoglobulin light chain is produced in the bone marrow and usually found in the blood or urine. AL amyloidosis occasionally occurs with multiple myeloma. The amyloid fibrils in this type of amyloidosis are made up of immunoglobulin light chain proteins (kappa or lambda).

Amyloidosis can only be diagnosed by a positive biopsy (i.e., an identification of the amyloid deposits in a piece of tissue). Initial biopsies are most commonly obtained from the abdominal fat.

If amyloid is suspected in other organs, however, a biopsy may be needed from these specific areas. If amyloid is present in a tissue biopsy, further tests can be done to determine the type of the amyloid.

The Amyloid Treatment & Research Program (ATRP) at Boston Medical Center (BMC) is an international referral center that treats amyloidosis with stem cell transplantation.

Last week researchers at Mayo Clinic have used urinary exosomes as a non-invasive diagnostic tool that will offer a snapshot of what is occurring in kidney tissue.

Urinary exosomes are rapidly becoming a powerful tool in the study of renal disease.

English: Urinary system

Already proteomics studies are looking into ways of using urinary exosome to diagnose genetic diseases and characterize disease biomarkers.

The urinary exosomes are excreted from every renal epithelial cells (from the glomerular podocytes to the urinary epithelial cells lining the urinary drainage system) provides us with an opportunity to study proteins once were either difficult or impossible to reach.

With this understanding the researchers undertook this study to evaluate the possible differences among urinary exosomes from patients with different plasma cells dyscrasias. This study suggests that urinary exosomes may be an excellent non-invasive tool for identifying patients with AL amyloidosis because high molecular weight light chain oligomers were found only in patients with AL.

The oligomeric light chain species captured in the urinary exosomes may represent the initial steps of amyloidogenesis. The potential of urinary exosomes in AL is tremendous and deserves further studies. When combined with mass spectrometry and other proteomics techniques, urinary exosomes represent tremendous potential to increase our understanding of amyloidogenesis.

Authors believe that this is the first report of the use of urinary exosome in the study of patients with plasma cell dyscrasias, specifically patients with AL amyloidosis.

References:

1. Amyloidosis: https://pharmaceuticalintelligence.com/2012/06/04/amyloidosis/

2. Alzheimers Disease: https://pharmaceuticalintelligence.com/category/alzheimers-disease-2/

3. Prospects for urinary proteomics: exosomes as a source of urinary biomarkers

4. Source article: Differences in Immunoglobulin Light Chain Species Found in Urinary Exosomes in Light Chain Amyloidosis (AL)

5.  Exosomal Fetuin-A identified by proteomics: a novel urinary biomarker for detecting acute kidney injury.

 6. Characterization of PKD protein-positive exosome-like vesicles.

7. Large-scale proteomics and phosphoproteomics of urinary exosomes.

8. Proteomic analysis of urinary exosomes from patients of early IgA nephropathy and thin basement membrane nephropathy.

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