• Sensitivity of MBI relative to sensitivity of mammography [ Time Frame: Mammogram and MBI must be done within 30 days ] [ Designated as safety issue: No ]
  

Device: Molecular Breast Imaging
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.

The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (~90%) for the detection of breast cancers independent of breast density.

The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. The study will comprise 2000 women with dense breast parenchyma and an increased risk of breast cancer based on a personal or family history, or a five-year risk of breast cancer that exceeds 1.7% by the Gail model. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.

This study will demonstrate that MBI has a high sensitivity and specificity for the detection of breast cancer in the high-risk dense breast population and may have a role as a routine screening tool. The low cost of an MBI procedure (5 to 10 times less than MRI) should make this a viable screening technique in this patient population.