Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754749
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-02-21
Brief Title:
Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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 pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis CE- DBT and contrast enhanced dynamic magnetic resonance imaging CE-MRI acquired as a part of a standard clinical workup
Detailed Description:
This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study Participants will be scanned with the DBT system after the administration of iodinated contrast agent Images will be acquired prior to the administration of contrast followed by at approximately 2 minutes and 5 minutes For the purposes of this study imaging will focus on a single breast to simplify data acquisition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None