Histology of Functional Density in Postmenopausal Breast

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.

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Key information

Conditions

Dense Breasts Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

proportion of epithelium vs stroma

Time frame: within 1 month of functional density assessment on MBI

Secondary outcomes

Degree of lobular involution

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2022
Study completion: 2022
First posted: Nov 15, 2010
Registry last updated: Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed