Clinical trial NCT06475066: Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
Official title: Clinical Effectiveness of cOntrast Enhanced Mammography in Diagnosis of Additional Findings at Preoperative Breast Magnetic ResOnance Imaging: A Prospective, Multicenter, Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Multicentric Lesion
Multifocal Lesion
Contrast Enhanced Spetral Mammography
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The detection rate of preoperative contrast-enhanced spectral mammography
timeFrame: within 28 days of MRI examination
Secondary outcomes:
measure: detection rate
timeFrame: within 28 days of MRI examination
measure: Number of Participants with change of treatment plan from baseline
timeFrame: within 28 days of MRI examination
measure: Number of Participants with change of biopsy plan from baseline
timeFrame: within 28 days of MRI examination
measure: diagnostic accuracy of CESM
timeFrame: within 28 days of MRI examination
measure: difference by MRI and CESM
timeFrame: within 28 days of MRI examination
Other outcomes:
measure: Safety Outcomes
timeFrame: During imaging procedure, 1 hour
measure: Safety Outcomes
timeFrame: During imaging procedure, 1 hour
Locations:
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
name: Fan Yang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: