Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- RSM mapping value
研究概览
简要总结
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.
详细描述
A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.
The aims of the study are as follows:
Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.
Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
- •Able to provide informed consent
排除标准
- •prior diagnosis of prostate cancer (Grade Group >1)
- •metastatic prostate cancer
- •prior prostate cancer treatment
- •contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
- •inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
- •Bilateral hip replacement
- •Unable to provide informed consent.
研究组 & 干预措施
MRI imaging using Siemens MRI
Participants enrolled will undergo routine Magnetic Resonance Imaging (MRI) to obtain Restricted Spectrum Mapping (RSM). These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
干预措施: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) (Other)
MRI imaging using Phillips MRI
Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
干预措施: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) (Other)
MRI imaging using General Electric (GE) MRI
Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
干预措施: Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) (Other)
结局指标
主要结局
RSM mapping value
时间窗: Baseline to approximately 9 months
Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.
次要结局
未报告次要终点
研究者
Mivchael Liss
Professor
University of California, San Diego