Status:
WITHDRAWN
3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
BRCA1 Mutation
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve in diagnosing breast cancer in women with high-risk of breast cancer.
Detailed Description
Life time risk of developing breast cancer is greatly elevated in women with familial breast cancer, especially in BRCA carriers. Prevention and early detection strategies in these high risk women inc...
Eligibility Criteria
Inclusion
- Women at high risk of developing breast cancer as outlined by the American Cancer society (ACS): women with known predisposing mutations (in BRCA1, 2 or PTEN genes), women with first degree relative who is a known carrier or has a 20% or more life time risk of breast cancer.
- The above high-risk women with a suspicious lesion classified as BIRADS 4 that is detected on mammography. Since the spatial resolution of 3.0-T breast MRI is similar to digital mammography, there is no limitation to the size of the mammographic lesion.
Exclusion
- Pregnancy or lactating women
- Contraindications for MRI:
- electrical implants (e.g. cardiac pacemakers or perfusion pumps)
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
- weight over 350 lbs
- Although a women meets our criteria for high risks for breast cancer and has an abnormal mammogram, she will be excluded from our study if her insurer does not provide payment for the breast MRI. The suspicious lesion will be biopsied under mammographic guidance as part of her standard of care. The third party carriers have been reimbursing payment for a breast MRI in these high risk women, especially after the ACS guidelines were released in 2007. Therefore, this outcome is unlikely to occur.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01409226
Start Date
August 1 2009
End Date
January 1 2012
Last Update
April 5 2012
Active Locations (1)
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1
NYU Medical Center
New York, New York, United States, 10016