Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging (COMBO-I)

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: contrast-enhanced spectral mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT06475066

UHCT230291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

320 participants in 1 patient group

Contrast-enhanced spectral mammography arm

Experimental group

Description:

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

Treatment:

Diagnostic Test: contrast-enhanced spectral mammography