Histology of Functional Density in Premenopausal Breast
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|ClinicalTrials.gov Identifier: NCT01588834|
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : May 20, 2016
|Condition or disease||Intervention/treatment|
|Dense Breasts Breast Cancer||Procedure: breast biopsy|
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|
|Actual Enrollment :||23 participants|
|Official Title:||Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Procedure: breast biopsy
- proportion of epithelium vs stroma [ Time Frame: within 3 days of functional density assessment on MBI ]
- Degree of lobular involution [ Time Frame: within 3 days 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 3 days 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588834
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Carrie B Hruska, PhD R-D||Mayo Clinic|