NCT01723124
Terminated
Not Applicable
Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Molecular Breast Imaging (MBI) scan
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.
Investigators
Deborah Rhodes
MD
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign \[Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2\]
Exclusion Criteria
- •Subjects will be excluded if they:
- •Are unable to understand and sign the consent form
- •Are pregnant or lactating
- •Are physically unable to sit upright and still for 40 minutes
- •Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- •Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
- •Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
- •Have undergone bilateral mastectomy
- •Have had a prior MBI within 20 months of scheduled study MBI.
Outcomes
Primary Outcomes
Molecular Breast Imaging (MBI) scan
Time Frame: Performed at Year 0 of study
The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
Secondary Outcomes
- Molecular Breast Imaging (MBI) scan(Performed at Year 2 of study)
Study Sites (1)
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