Status:
TERMINATED
Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Conditions:
Healthy, no Evidence of Disease
Eligibility:
FEMALE
30-50 years
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: Part...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01259076
Start Date
February 1 2011
End Date
July 1 2014
Last Update
April 10 2015
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611