Recruiting

MRI Software

Sponsor:

UCLA

Code:

NCT05882253

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05882253

Start date

Dec 4, 2023

Status verified date

Jul, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
  • Able to provide informed consent

Exclusion Criteria:

  • 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.

Study Design

Enrollment

225 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

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.

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.

Interventions

Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

An advanced imaging software that supports improved prostate cancer detection and diagnosis

Primary outcome measure

  • RSM mapping value [ Time Frame: Baseline to approximately 9 months ]

Central Contacts and Locations

Central contacts

Michael A Liss, MD, PhD

858-249-1240liss@health.ucsd.edu

Jessica Warbrick, ND

858-249-1240jwarbrick@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Michael A Liss, MD, PhD

858-249-1240Liss@health.ucsd.edu

Jessica Warbrick, ND

858-249-1240jwarbrick@health.ucsd.edu

Principal Investigator:

Michael Liss, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • Detection of prostate cancer
  • software application

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-07-17.