Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
NCT Number: NCT06475066
Acronym: COMBO-I
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: DIAGNOSTIC_TEST: contrast-enhanced spectral mammography
Sponsor: Wuhan Union Hospital, China
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

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.

Primary Outcome Measures: The detection rate of preoperative contrast-enhanced spectral mammography, 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)., within 28 days of MRI examination
Secondary Outcome Measures: detection rate, • Assess detection rate of CESM on the additional findings of breast MRI, within 28 days of MRI examination|Number of Participants with change of treatment plan from baseline, • Once CESM result is made available, the site investigators will be asked to re-evaluate the lesions and re-discuss the management strategy with site clinicians. Subsequent clinical management decisions such as biopsy or medical therapy is rested at the discretion of the referring clinicians and patients., within 28 days of MRI examination|Number of Participants with change of biopsy plan from baseline, • re-determining the treatment plan or biopsy plan and record the changes from baseline for each subject based on the clinical and radiology examination results, medical history and Breast Cancer Management Guideline (China HA 2022)., within 28 days of MRI examination|diagnostic accuracy of CESM, * Evaluate the accuracy of CESM when get histological examination report
* Protocols of clinical diagnosis, biopsy or therapeutic surgery, or histopathology examination will be conducted and reported according to the clinical routine of study sites., within 28 days of MRI examination|difference by MRI and CESM, * All breast MRI and CESM images will be re-evaluated in Wuhan Union Hospital (quality-control center) for image quality assessment by 2 independent radiologists (˃ 5 years' experience in diagnostic breast imaging) by Score of 5-point Likert scale and Score of 10-point Likert scale.
* For Score of 5-point Likert scale:

Score 1: insufficient image quality and cannot meet the diagnostic requirements Score 2: the image quality is average and basically meets the diagnostic requirements Score 3: The image quality is good and meets the diagnostic requirements Score 4: The image quality is good and meets the diagnostic requirements Score 5: The image quality is excellent and meets the diagnostic requirements

• For Score of 10-point Likert scale: 10 subscale scores for subjective overall evaluation and selection preferences for CESM inspections. 1 is the worst, 10 is the best., within 28 days of MRI examination
Other Outcome Measures: Safety Outcomes, Percentage of ADR in 1 hour post Iopromide administration, During imaging procedure, 1 hour|Safety Outcomes, Average gland dose (AGD) of CESM, During imaging procedure, 1 hour