Molecular Breast Imaging in the Preoperative Evaluation of Women With Biopsy Proven Breast Cancer
The sensitivity of conventional mammography for evaluation of extent of disease, detection
of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast
Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a
manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We
have developed the first dual-head MBI system in the world and preliminary results from this
system indicate a high sensitivity (~90%) for the detection of breast cancers < 10mm.
The AIM of this study is to determine the sensitivity of MBI relative to mammography in the
preoperative evaluation of the extent of disease in the ipsilateral and contralateral
breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is
more sensitive than mammography for preoperative evaluation and surgical planning.
The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All
patients will have a diagnostic mammogram and an MBI study prior to operation. At the time
of operation the pathologic findings will be correlated with both the mammogram and the MBI
This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1)
detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2)
detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with
pathologic size. These results may justify a role for MBI in the routine pre-operative
evaluation of breast cancer patients.
Observational Model: Case-Only, Time Perspective: Prospective
The gold standard for assessing MBI will be tissue pathology. Using pathology as the gold standard, we will compare the sensitivity of MBI to that of mammography in the evaluation of this patient population.
Michael K O'Connor, Ph.D.
United States: Institutional Review Board
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