NCT04992728

Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Restricted Spectrum Magnetic Resonance Imagining	Restriction Spectrum Magnetic Resonance Imaging (RS-MRI), which uses magnetism instead of x-rays to build up a picture of the inside of the body. The scan is completely painless but can be rather noisy and requires the patient to lie very still inside the center of a large, doughnut-shaped magnet for approximately 30-60 minutes complete the imaging.

Timeline

• Start date: 2021-11-02
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2021-08-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States