Histology of Functional Density in Postmenopausal Breast

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2022-04-27

Brief Summary

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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 hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.

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Detailed Description

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Conditions

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Dense Breasts Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age 40 or older
2. Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea
3. Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates

1. Negative or benign assessment (BIRADs category 1-2)
2. No proliferative benign lesions (e.g. fibroadenomas) identified
3. Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
4. MBI performed less than one month prior to biopsy demonstrating either significant FD or photopenic FD.

Exclusion Criteria

1. 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.
2. Personal history of any cancer, except non-melanomatous skin cancer
3. Current breast symptoms
4. Breast implants
5. Known allergy to local anesthetic.
6. History of bleeding complications from prior interventions
7. Current use of anticoagulants (e.g., Coumadin or other blood thinners)
8. Major medical condition

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes