Clinical Effectiveness of cOntrast Enhanced Mammography in Diagnosis of Additional Findings at Preoperative Breast Magnetic ResOnance Imaging: A Prospective, Multicenter, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The detection rate of preoperative contrast-enhanced spectral mammography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The detection rate of preoperative contrast-enhanced spectral mammography
时间窗: within 28 days of MRI examination
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).
次要结局
- Number of Participants with change of biopsy plan from baseline(within 28 days of MRI examination)
- detection rate(within 28 days of MRI examination)
- Number of Participants with change of treatment plan from baseline(within 28 days of MRI examination)
- diagnostic accuracy of CESM(within 28 days of MRI examination)
- difference by MRI and CESM(within 28 days of MRI examination)