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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, no Evidence of Disease

Intervention / Treatment
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* Procedure: magnetic resonance imaging
* Procedure: digital mammography
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Participants who are eligible for and have opted to undergo gastric bypass surgery | Procedure: magnetic resonance imaging<br>* Undergo MRI at baseline and 1 year later.<br>* Other names: nuclear magnetic resonance imaging;Procedure: digital mammography<br>* Undergo digital mammography at baseline and 1 year later.<br>Procedure: conventional surgery<br>* Undergo gastric bypass surgery<br>* Other names: surgery, conventional;|
| Group 2<br>Participants who are eligible for but decided not to undergo gastric bypass surgery. | Procedure: magnetic resonance imaging<br>* Undergo MRI at baseline and 1 year later.<br>* Other names: nuclear magnetic resonance imaging;Procedure: digital mammography<br>* Undergo digital mammography at baseline and 1 year later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI and breast density |  | At baseline and year 1 |