An interventional study of contrast-enhanced spectral mammography in Breast Cancer, sponsored by Wuhan Union Hospital, China. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Wuhan Union Hospital, China · Not applicable, Interventional, and Diagnostic
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.
Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receiving contrast-enhanced spectral mammography (CESM) within 28 days of MRI examination.
Diagnostic Test: 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.
Also known as: CEM, CESM
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).
Time frame: within 28 days of MRI examination
detection rate
• Assess detection rate of CESM on the additional findings of breast MRI
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: within 28 days of MRI examination
Safety Outcomes
Percentage of ADR in 1 hour post Iopromide administration
Time frame: During imaging procedure, 1 hour
Safety Outcomes
Average gland dose (AGD) of CESM
Time frame: During imaging procedure, 1 hour
Plan to share: No — China Policy does not allow investigator to disclose individual participant data.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Wuhan Union Hospital, China