Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer|
- Sensitivity of MBI relative to sensitivity of mammography [ Time Frame: Mammogram and MBI must be done within 30 days at Mayo Clinic Rochester ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Device: Molecular Breast Imaging
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.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Deborah J. Rhodes, M.D.||Mayo Clinic|