Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer

Terminated

• Conditions: Healthy, no Evidence of Disease
• Interventions: Procedure: magnetic resonance imaging; Procedure: digital mammography; Procedure: conventional surgery

• Registration Number: NCT01259076
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Study Start: 2011-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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

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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
• Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
• Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	conventional surgery	Participants who are eligible for and have opted to undergo gastric bypass surgery
Group 2	digital mammography	Participants who are eligible for but decided not to undergo gastric bypass surgery.
Group 1	digital mammography	Participants who are eligible for and have opted to undergo gastric bypass surgery
Group 1	magnetic resonance imaging	Participants who are eligible for and have opted to undergo gastric bypass surgery
Group 2	magnetic resonance imaging	Participants who are eligible for but decided not to undergo gastric bypass surgery.

Primary Outcome Measures

Name	Time	Method
Change in BMI and breast density	At baseline and year 1

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States