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

Northwestern University

Status: Terminated

Conditions: Healthy, no Evidence of Disease

Treatments: Procedure: conventional surgery; Procedure: digital mammography; Procedure: magnetic resonance imaging

Study type: Observational

Funder types: Other

Identifiers

NCT01259076

NU 10B01

STU00038177 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

Group 1

Description:

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

Treatment:

Procedure: digital mammography

Procedure: magnetic resonance imaging

Procedure: conventional surgery

Group 2

Description:

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

Treatment:

Procedure: digital mammography

Procedure: magnetic resonance imaging