Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detection of grade group ≥2 prostate cancer on histopathology
研究概览
简要总结
This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.
详细描述
Participants will undergo prostate MRI using a range of b-values and echo times. 40 participants will be invited to complete two such scans within 30 days of each other to evaluate reliability across time. Several advanced MRI models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on histopathology, obtained through routine clinical care. We hypothesize that advanced, multi-compartment dMRI will yield a reliable, quantitative metric that is superior to standard ADC for detection of csPCa.
RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion). The relative contributions of each compartment are estimated for each voxel in the imaging field of view. RSI cellularity index is a normalized parameter reflecting the contribution of very slow diffusion that is associated with tumor cellularity.
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
- •Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate
- •Has already undergone prostate MRI and/or scheduled to undergo clinically indicated radical prostatectomy (to permit whole-mount histopathology correlation).
- •Intended treatment and follow-up according to standard of care for prostate cancer
- •In good general health as evidenced by medical history and ECOG performance status 0-2
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
- •Hip prosthesis
- •Contraindication to MRI, per institutional requirements
- •Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
结局指标
主要结局
Detection of grade group ≥2 prostate cancer on histopathology
时间窗: 30 days
To determine an optimal quantitative dMRI technique for csPCa detection, we will implement an expanded dMRI protocol that will permit exploration of six different approaches, each with published evidence of advantages over conventional ADC. Accuracy will be evaluated using histopathology as the gold standard.
次要结局
- Inter-scan reliability(30 days)
研究者
Tyler Seibert
Assistant Professor of Medicine
University of California, San Diego