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Starting soon Not applicable

Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging

NCT06475066 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-07-01
Last updated
2024-06-26

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

contrast-enhanced spectral mammography

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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Adult women aged 18-75 years old * 2\. First-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days * 3\. Presenting with Index lesions of "BI-RADS≥4" and additional findings in preoperative breast MRI * 4\. Sign the informed consent form for this study. * 5\. Commit to follow the research procedures and cooperate with the implementation of the whole process of the study. * 6\. In the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period Exclusion Criteria: * 1\. Patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism * 2\. It has been more than 14 days since the most recent preoperative breast MRI was performed for the relevant breast disease * 3\. For the relevant breast disease, the preoperative breast MRI images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis * 4\. Patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy * 5\. Patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery * 6\. Other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with CESM examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements

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)

FacilityCityRegionStatus
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
Official registry record

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