Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy
研究概览
简要总结
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.
详细描述
ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Referred for mpMRI of the prostate for suspicion of prostate cancer
- •MRI is conducted using the standardized ART-Pro acquisition protocol
排除标准
- •Currently incarcerated
- •Previous diagnosis of prostate cancer
- •Active non-prostate tumor(s) in structures of the body near the prostate
- •Previous prostate surgery
- •History of hip implant
- •Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures
结局指标
主要结局
Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy
时间窗: 6 months
次要结局
- Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer(6 months)
研究者
Tyler Seibert
Associate Professor
University of California, San Diego