Histology of Functional Density in Premenopausal Breast

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Dense Breasts, Breast Cancer

Intervention / Treatment
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* Procedure: breast biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: breast biopsy|ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |