Software Development for Real-Time Radiotractor Guidance of Breast Biopsy

25 Software Development for Real-Time Radiotractor Guidance of Breast Biopsy--PEM Technologies, Inc., 5611 Roosevelt Street, Bethesda, MD 20817-6739; (301) 564-0835 Dr. Irving Weinberg, Principal Investigator Dr. Irving Weinberg, Business Official DOE Grant No. DE-FG02-97ER82449 Amount: $74,756 Innovative research using nuclear medicine technologies is necessary to advance the state of the art in noninvasive methods of diagnosing breast cancer. While detection of early breast cancer in women between the ages of 40 and 49 has been identified as a major societal issue by national health authorities, X-ray mammography can miss fully one quarter of cancers in patients of this age range. One possible adjunct to mammography would be highly specific radiotracer imaging, yet this imaging is limited by two critical factors: The current generation of detection hardware is not optimal for detecting the clinically important class of early small breast cancers, and clinical studies of such small cancers are hampered by the inability to compare radiotracer images of specific cases with correlative X-ray and biopsy results. In pilot clinical studies, a demonstration prototype device has been used that is capable of superimposing X-ray images of specific small cancers on images created with positron-emitting radiotracers. Image acquisition is performed on a conventional X-ray mammography platform that can provide biopsy correlations. In Phase I, algorithms will be integrated into a real-time display package, and limitations of the technique will be studied using positron emitting and single-photon-emitting point sources. Phase II technical development will include increasing the field-of-view of the demonstration cameras. Phase II clinical trials will definitively assess medically relevant parameters such as sensitivity and specificity in the detection of early breast cancer, as well as the accuracy of the device in assisting biopsy. Commercial Applications and Other Benefits as described by the awardee: The potential market for a reliable imaging device capable of direct breast biopsy is great, due to the high prevalence of breast cancer and the limitations of X-ray mammography.