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

This study has been withdrawn prior to enrollment.
(Due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01409226
First received: August 2, 2011
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Device: 3.0-T MRI
Procedure: biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of participants with incidental lesions detected by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    This is defined as the number of participants who have incidental lesions by MRI over the total number of participants.

    Incidental lesions are the lesions only detected by 3.0-T MRI, and not seen by mammography.


  • False positive rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The rate is defined as the percentage of participants who are diagnosed with breast cancer by MRI, yet not have the cancer. The MRI results will be compared with biopsy results with the pathology as the gold standard.

  • False negative rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The rate is defined as the percentage of participants who are diagnosed by pathology, yet not by MRI. The MRI results will be compared with biopsy results with the pathology as the gold standard.


Enrollment: 0
Study Start Date: August 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI Device: 3.0-T MRI
Participants undergo MRI prior to biopsy.
Procedure: biopsy
Participants undergo breast biopsy after 3.0-T MRI.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409226

Locations
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Linda Moy, MD New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01409226     History of Changes
Other Study ID Numbers: 09-0051
Study First Received: August 2, 2011
Last Updated: April 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
high-risk of breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier
diagnostic
MRI
BI-RADS 4
mammographically occult

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 16, 2014