Clinical Evaluation of Digital Mammography.

摘要

The investigations being conducted under DAMD award 17-999-I -9001 involve a unique group of expert physicists and clinical researchers who have previously collaborated to establish a research group known as the International Digital Mammography Group. Our study entails two aspects of translational research related to the clinical application of digital mammography: technology optimization (Phase I) & a clinical evaluation (Phase 2). The technology/system optimization work is near completion and has focused on optimizing the operational parameters most likely to impact mammographic image quality for radiodense breasts (x-ray tube target material, filter composition, tube voltage, and exposure level/radiation dose). Because the dynamic range of x-ray signals recorded with standard screen-film mammography systems is greatly exceeded by digital systems, one of the most promising contributions of digital mammography is improved imaging of moderate to markedly dense breast tissue. The second phase of this project is a multi-center clinical evaluation comparing optimized digital mammography to SFM in women with moderate or marked breast density who present for problem-solving mammography. Eligible women consenting to participate will undergo a 4-view screen-film and digital mammogram. The primary outcome of interest-lesion detectability on digital versus screen-film mammograms-will be evaluated based on a receiver operating characteristic curve analysis of 12 readers' assessments of the likely presence of malignant lesions based on mammographic findings. Secondarily, differences in case management between the two imaging modalities will be measured. Since 7115/2000,217 eligible patients have been enrolled in this trial (38 Group 1 patients, 107 Group 2 patients and 64 Group 3 patients), representing 20-25% ofthe total accrual planned for the study.