Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01409226
Status:
WITHDRAWN
Last Update Posted:
2012-04-05
First Post:
2011-08-02
Brief Title:
30 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Study to Evaluate 30 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to find out if 30 Tesla 30-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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None