Histology of Functional Density in Premenopausal Breast

Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Dense Breasts
• Intervention / Treatment: Procedure: breast biopsy

Detailed Description

The specific aims are:

• In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast.
• In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (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:

• 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)

Exclusion criteria:

• 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

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 3 days 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 3 days 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 3 days of functional density assessment on MBI

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic News
• Mayo Clinic You Tube Channel

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (ESTIMATE): May 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 12-000458