A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women
18 Years
70 Years
Female
Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Trial Information
A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women
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 include risk reducing surgery, chemoprevention and close surveillance with
semiannual clinical breast exams and yearly mammograms starting at age 25-35. Unfortunately,
screening mammography detects only half the breast cancers in mutation carriers, presumably
due to higher breast density in the younger women and perhaps due to inherent
characteristics of their tumors such as rapid growth. In light of these limitations in this
high risk group, some have suggested incorporation of semiannual mammograms and/or other
imaging modalities such as ultrasound (US) and MRI.
In this study, high risk women who have a suspicious mammographic lesion - categorized as
Breast Imaging Reporting and data System (BI-RADS) 4 will be recruited to undergo a breast
MRI before to a biopsy of the suspicious abnormality. All women will undergo a biopsy as a
part of her standard of care. The results of the MRI will not influence our decision on
whether a biopsy should be performed. The MRI results will be compared with the biopsy
results with pathology as the gold standard.
Inclusion Criteria:
- 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 Criteria:
- Pregnancy or lactating women
- Contraindications for MRI:
1. electrical implants (e.g. cardiac pacemakers or perfusion pumps)
2. 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
3. pre-existing medical conditions including a likelihood of developing seizures or
claustrophobic reactions, and any greater than normal potential for cardiac
arrest
4. 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI
Outcome Description:
This is the frequency of mammographically occult breast cancer detected by 3.0-T MRI in a subset of high risk women with a suspicious mammographically detected lesion.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Linda Moy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
09-0051
NCT ID:
NCT01409226
Start Date:
August 2009
Completion Date:
January 2012
Related Keywords:
- Breast Cancer
- BRCA1 Mutation
- BRCA2 Mutation
- high-risk of breast cancer
- BRCA1 mutation carrier
- BRCA2 mutation carrier
- diagnostic
- MRI
- BI-RADS 4
- mammographically occult
- Breast Neoplasms
Name | Location |
|---|---|
| NYU Medical Center | New York, New York 10016 |
