Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

Prostate Cancer Clinical Trial

— IMAGINED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882253
• Other study ID #: HSC20220897H
• Secondary ID: R01CA279667
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Michael A Liss, MD, PhD
• Phone: (210) 567-0548
• Email: Liss[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: April 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
An advanced imaging software that supports improved prostate cancer detection and diagnosis

Locations

Country	Name	City	State
United States	Audie Murphie VA	San Antonio	Texas
United States	The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center	San Antonio	Texas
United States	University Health System	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSM mapping value	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.	Baseline to approximately 9 months