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


N/A
30 Years
50 Years
Open (Enrolling)
Female
Healthy, no Evidence of Disease

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Change in BMI and breast density

Outcome Time Frame:

At baseline and year 1

Safety Issue:

No

Principal Investigator

Nora Hansen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 10B01

NCT ID:

NCT01259076

Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

  • Healthy, no Evidence of Disease
  • Weight Loss

Name

Location

Northwestern UniversityChicago, Illinois  60611