Histology of Functional Density in Postmenopausal Breast

Completed

• Conditions: Dense Breasts; Breast Cancer

• Registration Number: NCT01240278
• Lead Sponsor: Mayo Clinic

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of epithelium vs stroma	within 1 month of functional density assessment on MBI

Secondary Outcome Measures

Name	Time	Method
Degree of lobular involution	within 1 month of functional density assessment on MBI	Degree of lobular involution as assessed through qualitative and quantitative measurements will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.
Ki-67 cellular proliferation index	within 1 month of functional density assessment on MBI	Degree of cellular proliferation as assessed through Ki-67 index will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States