Conditions: Breast Cancer
Keywords: Dense breast tissue Breast Cancer Screening Molecular Breast Imaging Breast Cancer Breast
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 969
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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. 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.

Arms:
arm 1: Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.

Interventions: intervention 1: Molecular Breast Imaging intervention 2: Conventional Mammography intervention 3: Technetium (99mTc) sestamibi
Intervention descriptions: intervention 1: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors. intervention 2: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool. intervention 3: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.

Protocol document: