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NCT Number: NCT04992728

Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Gerald Henderson, BA

CONTACT

[email protected]

858-822-5223

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Restricted Spectrum Magnetic Resonance Imagining

Other

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

Primary outcomes

  1. Detection of grade group ≥2 prostate cancer on histopathology

    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.

Secondary outcomes

  1. Inter-scan reliability

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gerald Henderson, BA

CONTACT

[email protected]

858-534-4811

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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