Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-10
Brief Title:
Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Clinical Effectiveness of cOntrast Enhanced Mammography in Diagnosis of Additional Findings at Preoperative Breast Magnetic ResOnance Imaging A Prospective Multicenter Interventional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
COMBO-I
Brief Summary:
In order to explain the value of adding CESM into the clinical pathway and also to obtain the relevant clinical data to support future update of clinical guideline we plan to evaluate the detection rate of CESM for additional findings on preoperative breast MRI and the relevant clinical safety in the study
Detailed Description:
The goal of the prospective multicenter interventional Study is to prospectively evaluate the detection rate of preoperative contrast enhanced spectral mammography for additional suspicious findings of preoperative breast MRI in patients presenting with index breast lesions BI-RADS 4
The study plans to include 320 adult female patients with Index lesions of BI-RADS4 in breast MRI
The study plans to include 320 adult female patients with Index lesions of BI-RADS4 in breast MRI
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?:
None
Is an FDA AA801 Violation?:
None