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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
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.
Official title: Clinical Effectiveness of cOntrast Enhanced Mammography in Diagnosis of Additional Findings at Preoperative Breast Magnetic ResOnance Imaging: A Prospective, Multicenter, Interventional Study
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2024-07-01
Completion Date
2026-12-31
Last Updated
2024-06-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China