Histology of Functional Density in Premenopausal Breast

NCT01588834 | Completed DMC

• 1 other identifier: 12-000458
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.

Conditions

Dense Breasts; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• proportion of epithelium vs stroma

  within 3 days of functional density assessment on MBI

Secondary Outcomes (2)

• Degree of lobular involution

  within 3 days of functional density assessment on MBI

• Ki-67 cellular proliferation index

  within 3 days of functional density assessment on MBI

Interventions

breast biopsy PROCEDURE

ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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:

• Ages 40 - 55 years
• Considered premenopausal or peri-menopausal
• Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
• Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/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 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
• No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
• Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)

You may not qualify if:

• Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
• Prior diagnosis of bilateral breast cancer.
• Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
• Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
• 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

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 News
• Mayo Clinic You Tube Channel

Biospecimen

Retention: SAMPLES WITHOUT DNA

core biopsy samples from mammographically 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 B Hruska, PhD R-D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

US (1)