Feeds:
Posts
Comments

Posts Tagged ‘brest cancer screening in young women’


Couple of days ago I have posted on breast-cancer mammography screening and associated costs; Not applying evidence-based medicine drives up the costs of screening for breast-cancer in the USA. Treatment of breast-cancer represents much heavier cost-burden. According to the following publication: Variability in Reexcision Following Breast Conservation Surgery made in JAMA: “Failure to achieve appropriate margins at the initial operation will require additional surgery with re-excision rate estimates ranging from 30% to 60%. These additional operations can produce considerable psychological, physical, and economic stress for patients and delay use of recommended adjuvant therapies. A high percentage (10%-36%) of women requiring reexcision undergo total mastectomy. Thus, the effect of reexcision on altering a patient’s initial treatment of choice is significant.”

 Considering that ~70% of the 285,000 new patients diagnosed with breast cancer each year undergoes lumpectomy, this data represents significant cost. Not to mention morbidity, stress and reduce quality of life for the patients. In my post Optical Coherent Tomography – emerging technology in cancer patient management I discussed the potential of OCT in controlling the quality of lumpectomies in-situ. A workflow that represents potential to reduce the costs of repeated lumpectomies.

Last week, Dune Medical Devices, Inc., the company that developed the MarginProbeTM System, an intra-operative tissue assessment device to be used as accessory during lumpectomies of early-stage breast cancer, has received Premarket Approval (PMA) by the United States Food and Drug Administration.

MarginProbe system

marginProbe

FDA approval of the MarginProbe System was based on a 664 patient prospective, multi-center, randomized, double arm study to evaluate the effectiveness of MarginProbe in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures. MarginProbe, which uses electromagnetic “signatures” to identify healthy and cancerous tissue, was found to be over three times more effective in finding cancer on the margin during lumpectomy, compared to traditional intra-operative imaging and palpation assessment. This enabled surgeons to significantly reduce the number of patients with positive margins following initial surgery.

The following publication gives an idea on the clinical performance of MarginProbe:

J Surg Res. 2010 May 15;160(2):277-81. doi: 10.1016/j.jss.2009.02.025. Epub 2009 Mar 31.

Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens.

Pappo ISpector RSchindel AMorgenstern SSandbank JLeider LTSchneebaum SLelcuk SKarni T.

Source

Department of General Surgery, Assaf Harofeh Medical Center, Zrifin, Israel. pappo@zahav.net.il

Abstract

BACKGROUND:

Margin status in breast lumpectomy procedures is a prognostic factor for local recurrence and the need to obtain clear margins is often a cause for repeated surgical procedures. A recently developed device for real-time intraoperative margin assessment (MarginProbe; Dune Medical Devices, Caesarea, Israel), was clinically tested. The work presented here looks at the diagnostic performance of the device.

METHODS:

The device was applied to freshly excised lumpectomy and mastectomy specimens at specific tissue measurement sites. These measurement sites were accurately marked, cut out, and sent for histopathologic analysis. Device readings (positive or negative) were compared with histology findings (namely malignant, containing any microscopically detected tumor, or nonmalignant) on a per measurement site basis. The sensitivity and specificity of the device was computed for the full dataset and for additional relevant subgroups.

RESULTS:

A total of 869 tissue measurement sites were obtained from 76 patients, 753 were analyzed, of which 165 were cancerous and 588 were nonmalignant. Device performance on relatively homogeneous sites was: sensitivity 1.00 (95% CI: 0.85-1), specificity 0.87 (95% CI: 0.83-0.90). Performance for the full dataset was: sensitivity 0.70 (95% CI: 0.63-0.77), specificity 0.70 (95% CI: 0.67-0.74). Device sensitivity was estimated to change from 56% to 97% as the cancer feature size increased from 0.7 mm to 6.6 mm. Detection rate of samples containing pure DCIS clusters was not different from rates of samples containing IDC.

CONCLUSIONS:

The device has high sensitivity and specificity in distinguishing between normal and cancer tissue even down to small cancer features.

Copyright (c) 2010 Elsevier Inc. All rights reserved.

PMID: 19628225

Imagine how cost effective breast cancer management can be if it will involve systems such as these in addition to the systems I discussed in some of my previous posts, for example: What could transform an underdog into a winner?

Written by: Dror Nir, PhD.

Read Full Post »


There are 40 million women seeking mammography breast-screening every year in the USA, out of which 15 million are women with heterogeneously dense or extremely dense breasts. USA epidemiology statistics show that 6 out of 7 missed cancers at mammography occur in women with dense breasts. It is also known that the majority of women presenting with mammography-dense breasts are below 45 years old.

The Oct. 22 issue of the American Journal of Roentgenology ( AJR) publishes results of a study showing that ultrasound is superior to mammography in evaluating symptomatic women 30-39 years of age [1].

This study was conducted by researchers at the Seattle Cancer Alliance and University of Washington. Patients were recruited between January 2002 and August 2006.   954 women ranging from 30 to 39 years old who presented for diagnostic breast imaging evaluation were  examined, and it was found that sensitivity (probability for cancer detection) of ultrasound was 95.7 percent compared to 60.9 percent for mammography. A very important result of this study is the calculated Negative Predictive Value (the probability to have negative pathology if the imaging-test is negative) which was similar for both modalities: 99.9% for ultrasound and 99.2% for mammography.

Show case in images (All images courtesy of the American Roentgen Ray Society.):

35-year-old woman who presented with a palpable left breast lump. Whole-breast craniocaudal (above left) and mediolateral oblique (above right) and spot-magnification craniocaudal (below left) and mediolateral (below right) mammographic images show no abnormality at area of clinical concern, marked by BB.

Zoom-in on the region of interest

Targeted ultrasound image above reveals solid mass with irregular shape and indistinct and angular margins. BI-RADS 5 assessment was made. Histopathology from ultrasound-guided core needle biopsy showed invasive ductal carcinoma.

In regards to which imaging modality should be used when screening such a population, the conclusion of the investigators is very clear: “Ultrasound has high sensitivity (95.7%) and high NPV (99.9%) in this setting and should be the primary imaging modality of choice. The added value of adjunct mammography is low.”

When reading this article I noted a gap to overcome if we want to successfully replace mammography with ultrasound. The Positive Predictive Value (the probability of  detecting a cancer) calculated for ultrasound in these study settings was lower than that calculated for mammography: 13.2% for ultrasound and 18.4% for mammography. This is because mammography detected one additional malignancy in an asymptomatic area in a 32-year-old woman who was subsequently found to have a BRCA2 gene mutation. Mammography could do that because it scans the whole breast, whereas the investigators in this study used ultrasound just for scanning the suspicious lumps. A solution is offered in using the recently introduced ultrasound modalities, which are able to perform automatic full breast ultrasound scans [2], preferably enhanced by real-time tissue characterisation capability – a technology I’m working to develop.

References:

  1. Accuracy and Value of Breast Ultrasound for Primary Imaging Evaluation of Symptomatic Women 30-39 Years of Age,Constance D. Lehman1,2Christoph I. Lee1,2Vilert A. Loving1,2, Michael S. Portillo1,2Sue Peacock1,2 and Wendy B. DeMartini1,2, Oct. 22 issue of the American Journal of Roentgenology
1 Department of Radiology, University of Washington School of Medicine, Seattle WA.
2 Seattle Cancer Care Alliance, G2-600, 825 Eastlake Ave E, Seattle, WA 98109.

2. Using Automated Breast Sonography as Part of a Multimodality Approach to Dense Breast Screening, Vincenzo Giuliano, MD, RDMS, RVT1, Concetta Giuliano, DO1, Journal of Diagnostic Medical SonographyJuly/August 2012 28: 159-165,

1Novasoutheastern University, Winter Springs, FL, USA
 
 
Written by: Dror Nir, PhD.

Read Full Post »