Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-enhanced spectral mammography arm | Experimental | Subjects receiving contrast-enhanced spectral mammography (CESM) within 28 days of MRI examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contrast-enhanced spectral mammography | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes | Percentage of ADR in 1 hour post Iopromide administration | During imaging procedure, 1 hour |
| Safety Outcomes | Average gland dose (AGD) of CESM |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Yang, Dr. | Contact | 008685726114 | fyang@vip.163.com | |
| Juan Tao, Dr. | Contact | 008685726114 | taojuan@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fan Yang, Dr. | Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
China Policy does not allow investigator to disclose individual participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| within 28 days of MRI examination |
| difference by MRI and CESM |
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 |
| During imaging procedure, 1 hour |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided