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

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

NCT ID: NCT06475066

Condition: Breast Cancer

Conditions: Keywords:
Multicentric Lesion
Multifocal Lesion
Contrast Enhanced Spetral Mammography

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: contrast-enhanced spectral mammography
Description: 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.
Arm group label: Contrast-enhanced spectral mammography arm

Other name: CEM

Other name: CESM

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430000
Country: China

Start date: July 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Wuhan Union Hospital, China
Agency class: Other

Source: Wuhan Union Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06475066