3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women

NCT ID: NCT01409226

Last Updated: 2012-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-01-31

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.

Conditions

Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI

Group Type: EXPERIMENTAL

3.0-T MRI

Intervention Type: DEVICE

Participants undergo MRI prior to biopsy.

biopsy

Intervention Type: PROCEDURE

Participants undergo breast biopsy after 3.0-T MRI.

Interventions

3.0-T MRI

Participants undergo MRI prior to biopsy.

Intervention Type: DEVICE

biopsy

Participants undergo breast biopsy after 3.0-T MRI.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Moy, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

09-0051

Identifier Type: -

Identifier Source: org_study_id