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.
Procedure: Molecular Breast Imaging
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Locations near you
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Full eligibility criteria for NCT01723124
Ages eligible for Study
40 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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]
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.
All locations for NCT01723124
United States (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
View full eligibility
Tris trial is registered with FDA with number: NCT01723124. The sponsor of the trial is Mayo Clinic and it is looking for 228 volunteers for the current phase.
Official trial title: 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
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