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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01259076

Enrollment

Registered

2010-12-13

Start date

2011-02-28

Completion date

2014-07-31

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, no Evidence of Disease

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.

Interventions

PROCEDUREmagnetic resonance imaging

Undergo MRI at baseline and 1 year later.

PROCEDUREdigital mammography

Undergo digital mammography at baseline and 1 year later.

PROCEDUREconventional surgery

Undergo gastric bypass surgery

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in BMI and breast density	At baseline and year 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026