An official website of the United States government
Artificial Intelligence and MRI-Derived Quantitative Risk Maps for Prostate Cancer Diagnosis
Trial Status: active
This clinical trial tests and validates an artificial intelligence-based tool for creating magnetic resonance imaging (MRI)-derived quantitative risk maps for prostate cancer diagnosis. The Risk Map Decision Support System (DSS) is an artificial intelligence-based tool that uses image analysis software to automatically interpret images of the prostate that were captured using an MR (magnetic resonance) scanner (an imaging technique that uses scanners to take pictures of the body). This tool can potentially identify additional areas of cancer in the prostate that may have otherwise been missed. This study is being done because the Risk Map DSS tool may provide critical information to guide therapy and improve outcomes for prostate cancer patients.
Inclusion Criteria
Patients with known or suspected prostate cancer (PCa) who have been referred for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate
Voluntary written informed consent before the MRI examination
Exclusion Criteria
Subjects incapable of giving informed written consent
Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders
Prisoners
Minor children (under the age of 18 years old)
Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for PCa
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05710380.
I. To compare the accuracy of the Risk Map Decision Support Systems (DSS) tool against the clinical accuracy of experienced radiologists in the context of the reference standard of biopsy histology.
OUTLINE:
Patients undergo MRI on study. Patients also undergo transrectal MRI-guided prostate biopsy during follow up.
After completion of study intervention, patients are followed up for 12 months after enrollment.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
