Histology of Functional Density in Postmenopausal Breast

Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Dense Breasts

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of epithelium vs stroma	within 1 month of functional density assessment on MBI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of lobular involution	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.	within 1 month of functional density assessment on MBI
Ki-67 cellular proliferation index	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.	within 1 month of functional density assessment on MBI

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 10-004506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No