Authors' objectives:

The aim of this review was to assess the evidence on the use of computer-aided detection (CAD) with magnetic resonance imaging (MRI) of the breast by comparing the sensitivity, specificity, and recall rate1 of MRI with and without the use of commercially available CAD systems in detecting malignant lesions, evaluating the extent of disease in women with cancer, or gauging the impact of treatment.

Authors' results and conclusions: Many of the studies on the use of CAD with MRI of the breast primarily report on the development of CAD systems or testing new CAD approaches. Few of them evaluate commercially available CAD systems. Several of those that do, report on the development and testing of approaches that underlie one of the commercially available systems (3TP); it is not clear to what degree the current 3TP system has or has not been modified compared to these earlier approaches. Although the studies had to have separate testing data sets to be included in this Assessment, these data sets often were enriched with more cancer cases or consisted exclusively of cases in which lesions had been found. As a result, the range of sensitivities and specificities cannot be applied to the populations usually found in a clinical setting. In addition, because many of the studies are retrospective and report primarily on the development and testing of a CAD system, they lack the rigor and generalizability of a large, prospective, well-designed study.

Authors' recommendations: Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether the computer-aided detection of malignancy with MRI of the breast meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. Two CAD systems for use with MRI of the breast have 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. There are no high quality, current published studies of the impact of commercially available CAD systems on the sensitivity and specificity of MRI of the breast. The few studies and abstracts available focus primarily on the development of the CAD system or they include samples of women that are highly selective and usually have far more cases of cancer than would be encountered in a screening population. 3. The technology must improve the net health outcome; and 4. The technology must be as beneficial as any established alternatives. There is insufficient evidence to assess whether the use of CAD systems would maintain or increase the sensitivity, specificity, and recall rates of MRI of the breast. Given the inability to evaluate these intermediate outcomes, it is not possible to assess the impact of CAD on health outcomes such as treatment success among breast cancer patients or survival. 5. The improvement must be attainable outside the investigational settings. Whether the use of CAD with MRI of the breast improves outcomes has not been established in the investigational setting. For the above reasons, computer-aided detection of malignancy with MRI of the breast does not meet the TEC criteria.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)