MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Chicago
About this trial
Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Risk Map Decision Support System (DSS).
Other interventionThe Risk Map DSS tool is an image analysis software that automatically interprets 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 your prostate that may have otherwise been missed.
Magnetic Resonance Imaging (MRI)
RadiationA medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.
Magnetic Resonance Imaging (MRI) Guided Biopsy
Procedure/SurgeryA removal of tumor tissue from the body based on images of the prostate provided by a previous magnetic resonance imaging (MRI) test. Up to 2 biopsies on trial.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: All Participants (Single Arm)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Decision Map Tool Compared to Oncologists
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov