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

NCT ID: NCT06475066

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast-enhanced spectral mammography arm

Subjects receiving contrast-enhanced spectral mammography (CESM) within 28 days of MRI examination.

Group Type: EXPERIMENTAL

contrast-enhanced spectral mammography

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CEM; CESM

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fan Yang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Locations

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Fan Yang, Dr.

Role: CONTACT

fyang@vip.163.com

008685726114

Juan Tao, Dr.

Role: CONTACT

taojuan@hust.edu.cn

008685726114

Other Identifiers

UHCT230291

Identifier Type: -

Identifier Source: org_study_id