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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Healthy, no Evidence of Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Participants who are eligible for and have opted to undergo gastric bypass surgery

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo MRI at baseline and 1 year later.

digital mammography

Intervention Type PROCEDURE

Undergo digital mammography at baseline and 1 year later.

conventional surgery

Intervention Type PROCEDURE

Undergo gastric bypass surgery

Group 2

Participants who are eligible for but decided not to undergo gastric bypass surgery.

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo MRI at baseline and 1 year later.

digital mammography

Intervention Type PROCEDURE

Undergo digital mammography at baseline and 1 year later.

Interventions

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magnetic resonance imaging

Undergo MRI at baseline and 1 year later.

Intervention Type PROCEDURE

digital mammography

Undergo digital mammography at baseline and 1 year later.

Intervention Type PROCEDURE

conventional surgery

Undergo gastric bypass surgery

Intervention Type PROCEDURE

Other Intervention Names

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MRI NMR imaging NMRI nuclear magnetic resonance imaging surgery, conventional

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes