Clinical trial NCT01409226: 3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
Official title: A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Keywords: high-risk of breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier
diagnostic
MRI
BI-RADS 4
mammographically occult
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of participants with incidental lesions detected by MRI
timeFrame: 2 years
measure: False positive rate
timeFrame: 2 years
measure: False negative rate
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Linda Moy, MD
role: PRINCIPAL_INVESTIGATOR
References: