Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI

Northwestern University1 site in 1 country43 target enrollmentFebruary 2011

ConditionsHealthy, no Evidence of Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy, no Evidence of Disease
Sponsor: Northwestern University
Enrollment: 43
Locations: 1
Primary Endpoint: Change in BMI and breast density
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

Detailed Description

OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

July 2014

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Northwestern University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women eligible for gastric bypass surgery
•Pre-menopausal women
•All women will have signed an informed consent form prior to participating in study procedures

Exclusion Criteria

•Women with a history of breast cancer
•Women currently taking exogenous hormone replacement therapy
•Women currently taking a SERM
•Women currently taking an aromatase inhibitor
•Pregnant or lactating women
•Women who have been pregnant or lactating in the past 2 years
•Women who have metallic or other surgical implants
•All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
•Subjects should not have a known history of recent onset acute renal dysfunction
•Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below