Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer
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 3500 women. Initial recruitment will be from the pool of
patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic
Rochester. 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.
Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Sensitivity of MBI relative to sensitivity of mammography
Mammogram and MBI must be done within 30 days at Mayo Clinic Rochester
Deborah J. Rhodes, M.D.
United States: Institutional Review Board
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