Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
Condition(s) studied
Investigational drug(s) / intervention(s)
contrast-enhanced spectral mammography: After enrollment, subjects should undergo contrast-enhanced spectral mammography again within within 28 days of MRI examination. Iopromide/contrast agent is intravenously administered two minutes prior to the first (dual-energy) image acquisition. * The dosage of iodine contrast agent is calculated as 1.5 mL/kg of iopromide 370 mgI/ml. * Injecting with high pressure syringe (Stellant, Bayer AG) at an IDR of 3ml/s, followed by 10 ml normal saline.
Study 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.
Eligibility
Primary outcome measure(s)
- The detection rate of preoperative contrast-enhanced spectral mammography — within 28 days of MRI examination
The detection rate of preoperative contrast-enhanced spectral mammography in 28 days after breast MRI for the detection of additional MRI findings in patients with breast index lesions (BI-RADS ≥ 4). The efficacy analysis data set of the study included all subjects who have obtained breast MRI and CESM with adequate image quality (score ≥ 2 of the 1-5 rating scale).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06475066 on ClinicalTrials.gov ↗ ← All trials in China