Histology of Functional Density in Postmenopausal Breast

NCT01240278 | Completed

• 1 other identifier: 10-004506
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dense Breasts; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• proportion of epithelium vs stroma

  within 1 month of functional density assessment on MBI

Secondary Outcomes (2)

• Degree of lobular involution

  within 1 month of functional density assessment on MBI

• Ki-67 cellular proliferation index

  within 1 month of functional density assessment on MBI

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Bardwell Speltz L, Ghosh K, Visscher DW, Scott CG, Cole KC, Kroneman TN, Maxwell RW, Conners AL, Hunt KN, Rhodes DJ, Vachon CM, Hruska CB. Histologic correlates of background parenchymal uptake on molecular breast imaging. Breast Cancer Res. 2025 Dec 16;27(1):216. doi: 10.1186/s13058-025-02171-x.

  PMID: 41402965 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

core biopsy samples of dense breast tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carrie Hruska, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)