Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-18 @ 10:51 AM
Study NCT ID:
NCT06475066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
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-RADS≥4" in breast MRI.
The study plans to include 320 adult female patients with Index lesions of "BI-RADS≥4" in breast MRI.
Study Oversight
Has Oversight DMC:
False
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?: