Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877912
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2021-04-28
Brief Title:
Accurate Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Development and Testing of an Accurate Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk MRI combined with other methods of risk assessment has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage with far fewer interval cancers than mammography Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer
Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists Based on the radiologist determination that the MRI findings are suspicious these findings include masses non-mass enhancement and foci suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary These are Bi-Rads codes 0 4 and 5 False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging
Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists Based on the radiologist determination that the MRI findings are suspicious these findings include masses non-mass enhancement and foci suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary These are Bi-Rads codes 0 4 and 5 False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None