RecruitingRecruiting
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
NCT06579417 · University of California, San Diego
In plain English
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Official title
Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
About this study
ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Currently incarcerated
* Previous diagnosis of prostate cancer
* Active non-prostate tumor(s) in structures of the body near the prostate
* Previous prostate surgery
* History of hip implant
* 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
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-12-15
Estimated completion: 2029-07
Last updated: 2024-11-06
Interventions
Diagnostic Test: RSI MRI
Primary outcomes
- • Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy (6 months)
Sponsor
University of California, San Diego · other
With: GE Healthcare, University of California, San Francisco, Massachusetts General Hospital, Weill Medical College of Cornell University, Cambridge University Hospitals NHS Foundation Trust
Contacts & investigators
ContactTyler Seibert, MD, PhD · contact · tseibert@health.ucsd.edu · 858-246-2180
InvestigatorTyler Seibert, MD, PhD · principal_investigator, University of California, San Diego
All locations (5)
University of California San DiegoRecruiting
San Diego, California, United States
University of California, San FranciscoNot Yet Recruiting
San Francisco, California, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Weill Cornell Medical CollegeNot Yet Recruiting
New York, New York, United States
Cambridge University Hospitals NHS Foundation TrustNot Yet Recruiting
Cambridge, Cambridgeshire, United Kingdom