3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
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|ClinicalTrials.gov Identifier: NCT01409226|
Recruitment Status : Withdrawn (Due to slow accrual)
First Posted : August 4, 2011
Last Update Posted : April 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer BRCA1 Mutation BRCA2 Mutation||Device: 3.0-T MRI Procedure: biopsy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Device: 3.0-T MRI
Participants undergo MRI prior to biopsy.
Participants undergo breast biopsy after 3.0-T MRI.
- Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI [ Time Frame: 2 years ]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 ]
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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|