Histology of Functional Density in Premenopausal Breast

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588834
• Other study ID #: 12-000458
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2012
• Last updated: May 19, 2016
• Start date: April 2012
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Dense Breasts

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of epithelium vs stroma		within 3 days of functional density assessment on MBI	No
Secondary	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	No
Secondary	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	No

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