3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
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.
Device: 3.0-T MRI
|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|
- 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.
- 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.
|Study Start Date:||August 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Device: 3.0-T MRI
Participants undergo MRI prior to biopsy.Procedure: biopsy
Participants undergo breast biopsy after 3.0-T MRI.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409226
|United States, New York|
|NYU Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Linda Moy, MD||New York University School of Medicine|