Clinical evaluation of a new digitizing device for improved film mammography.

RATIONALE AND OBJECTIVES: The study was designed to evaluate a new digitizing device, the iView (Maxxvision, LLC, Gainesville, FL), which aims to replace the magnifying glass in mammography with real-time film digitization, display, and processing. MATERIALS AND METHODS: A receiver operating characteristic (ROC) experiment was performed with 5 certified mammographers and 114 mammograms that were read with and without the iView. A satisfaction survey was also conducted on the system's features and usefulness. RESULTS: Data analysis suggested that (1) Cancer sensitivity could improve with the use of the iView system. ROC area differences showed improvements from 2% to 24% although these were not always statistically significant. At a false positive rate of 0.2, the true positive rate increased up to 60% depending on the set of cases and the observer's experience. (2) Specificity could also be improved. At a true positive rate of 0.9, the false positive rate decreased by as much as 55%. (3) Most observers felt more confident in their decisions when using the iView, although the prototype's ergonomic problems did not allow full utilization of its capabilities. CONCLUSION: Our pilot clinical study showed that the iView has the potential to improve mammogram interpretation. In addition, the system could broaden the applicability of electronic information and provide wider access to digital technology through a relatively simple and cost-effective approach. Observers recommended several improvements in the ergonomics and default display of the system that are currently implemented by the company. A larger clinical study of the improved system is necessary to clearly demonstrate its clinical value for mammography.

Radioactive seed localization breast biopsy and lumpectomy: can specimen radiographs be eliminated?

BACKGROUND: Wire localization (WL) is the current standard for surgical diagnosis of nonpalpable breast lesions. Many disadvantages inherent to WL are solved with radioactive seed localization (RSL). This trial investigated the ability of RSL to reduce the need for specimen radiographs and operating room delays associated with WL. METHODS: A total of 134 women were entered onto an institutional review board-approved study. RSL was performed by placing a titanium seed containing.29 to 20 mCi of iodine-125 to within 1 cm of the suggestive breast lesion. The surgeon used a handheld gamma detector to locate and excise the iodine-125 seed and the lesion. RESULTS: Specimen radiographs were eliminated in 98 (79%) of 124 patients. Surgical seed retrieval was 100% in 124 patients. No seed migration occurred after correct radiographical placement. A total of 26 (21%) of 124 patients required a specimen radiograph; 22 (85%) of these 26 were performed for microcalcifications. CONCLUSIONS: After surgical removal, RSL can eliminate specimen radiographs when the radiologist accurately places the seed and the pathologist grossly identifies the lesion. If small microcalcifications are noted before surgery, then specimen radiographs may be necessary. RSL reduced requirements for specimen radiographs, decreased OR time, improved incision placement, and improved resections to clear margins.