Histology of Functional Density in Premenopausal Breast
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
First received: April 26, 2012
Last updated: May 8, 2015
Last verified: May 2015
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.
Procedure: breast biopsy
||Observational Model: Cohort
Time Perspective: Prospective
||Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women
Primary Outcome Measures:
- proportion of epithelium vs stroma [ Time Frame: within 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Degree of lobular involution [ Time Frame: within 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ]
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 3 days of functional density assessment on MBI ] [ Designated as safety issue: No ]
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.
core biopsy samples from mammographically dense breast tissue
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
Procedure: breast biopsy
ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
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
|Ages Eligible for Study:
||40 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI
- 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)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588834
|Rochester, Minnesota, United States, 55905 |
||Carrie B Hruska, PhD R-D
No publications provided
ClinicalTrials.gov processed this record on September 03, 2015
||Carrie Hruska, Principal Investigator, Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2012
||May 8, 2015
||United States: Institutional Review Board