UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Location status: Recruiting
NCT Number: NCT04992728
This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.
Interested in participating?
Request Info18 year and older
Male
Observational
La Jolla, California, 92093, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: RSI MRI, Diffusion MRI
Time frame: 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.
Time frame: 30 days
Reliability is a critical feature of quantitative imaging biomarkers. Prostate MRI is known to vary with physiologic conditions, such as bowel activity, bowel/bladder filling, and recency of ejaculation(5). Patients planning to undergo prostatectomy (to permit whole-mount histopathology correlation) will be invited to consent to a second MRI scan on a different date, within approximately 30 days of the first scan (to avoid meaningful change in any tumor). The across-date reproducibility coefficient will be calculated for each metric
Contact information is provided by the study sponsor or research team.
University of California, San Diego
Other
Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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