Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants
研究概览
简要总结
The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).
详细描述
If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.
After your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.
This is an investigational study. The short breast MRI is considered investigational.
Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years and older female patients
- •BMRI indication: high risk screening per ACS guidelines
- •No contraindications to undergo MRI
- •Creatinine </=1.3 and GFR> 40
- •No requirement for sedation.
排除标准
- •Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
- •Contraindication to Gd contrast agents
- •Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
- •Contraindications to MRI
结局指标
主要结局
Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants
时间窗: 1 day
Radiologists blinded to patient outcome review images from each study independently and rate the possibility of breast cancer using BI-RADS score. BIRADS 0, 3,4, 5 considered positive, BIRADS 1 and 2 considered negative results for the analysis. Each reader's score for a given case assessed both independently and on a separate session, as consensus.
次要结局
未报告次要终点