RECRUITING

ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-15
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06579417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Referred for mpMRI of the prostate for suspicion of prostate cancer
  3. * MRI is conducted using the standardized ART-Pro acquisition protocol
  1. * Currently incarcerated
  2. * Previous diagnosis of prostate cancer
  3. * Active non-prostate tumor(s) in structures of the body near the prostate
  4. * Previous prostate surgery
  5. * History of hip implant
  6. * Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures

Contacts and Locations

Study Contact

Tyler Seibert, MD, PhD
CONTACT
858-246-2180
tseibert@health.ucsd.edu

Principal Investigator

Tyler Seibert, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California San Diego
San Diego, California, 92037
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Weill Cornell Medical College
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Tyler Seibert, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-15
Study Completion Date2029-07

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Prostate cancer
  • Multiparametric MRI
  • Biparametric MRI
  • Restriction Spectrum Imaging

Additional Relevant MeSH Terms

  • Prostate Cancer