Back to results3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
Primary Purpose
Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3.0-T MRI
biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring high-risk of breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier, diagnostic, MRI, BI-RADS 4, mammographically occult
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:
- 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.
Sites / Locations
- NYU Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI
Arm Description
Outcomes
Primary Outcome Measures
Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01409226
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Due to slow accrual
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
3.0-T MRI
Intervention Description
Participants undergo MRI prior to biopsy.
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
Participants undergo breast biopsy after 3.0-T MRI.
Primary Outcome Measure Information:
Title
Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Percentage of participants with incidental lesions detected by MRI
Description
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.
Time Frame
2 years
Title
False positive rate
Description
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.
Time Frame
2 years
Title
False negative rate
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Moy, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
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