RecruitingNCT04992728
Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI
Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
Sponsor
University of California, San Diego
Enrollment
100 participants
Start Date
Nov 2, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria6
- 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
Exclusion Criteria4
- 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.
Interventions
OTHERRestricted 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04992728
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