Status:
COMPLETED
Histology of Functional Density in Postmenopausal Breast
Lead Sponsor:
Mayo Clinic
Conditions:
Dense Breasts
Breast Cancer
Eligibility:
FEMALE
40+ years
Brief Summary
Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 40 or older
- Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea
- Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- Negative or benign assessment (BIRADs category 1-2)
- No proliferative benign lesions (e.g. fibroadenomas) identified
- Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
- MBI performed less than one month prior to biopsy demonstrating either significant FD or photopenic FD.
- Exclusion criteria:
- Using any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones) or any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
- Personal history of any cancer, except non-melanomatous skin cancer
- Current breast symptoms
- Breast implants
- Known allergy to local anesthetic.
- History of bleeding complications from prior interventions
- Current use of anticoagulants (e.g., Coumadin or other blood thinners)
- Major medical condition
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01240278
Start Date
November 1 2010
End Date
April 27 2022
Last Update
July 26 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905