Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Referred for mpMRI of the prostate for suspicion of prostate cancer

• MRI is conducted using the standardized ART-Pro acquisition protocol

Locations
United States
California
University of California San Diego
RECRUITING
San Diego
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
New York
Weill Cornell Medical College
NOT_YET_RECRUITING
New York
Other Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Cambridge
Contact Information
Primary
Tyler Seibert, MD, PhD
tseibert@health.ucsd.edu
858-246-2180
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2029-07
Participants
Target number of participants: 500
Treatments
ART-Pro-1
Related Therapeutic Areas
Sponsors
Collaborators: GE Healthcare, Weill Medical College of Cornell University, Cambridge University Hospitals NHS Foundation Trust, Massachusetts General Hospital, University of California, San Francisco
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov