Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05882253

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.

The aims of the study are as follows:

Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.

Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Other

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

Other names: On-Q Prostate

Primary outcomes

  1. RSM mapping value

    Time frame: Baseline to approximately 9 months

    Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.

Study contacts

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

Jessica Warbrick, ND

CONTACT

[email protected]

858-249-1240

Michael A Liss, MD, PhD

CONTACT

[email protected]

858-249-1240

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer

Acronym: IMAGINED

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 31, 2023
Registry last updated
Jul 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.