MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05710380
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Risk Map Decision Support System (DSS). — OTHER
    The 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) — RADIATION
    A 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
    A 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.

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
Sep 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: All Participants (Single Arm)
    All participants in this trial will be provided with routine instructions and precaution information before starting the magnetic resonance (MRI) scan. After the MRI, participants will undergo an MRI-guided fusion biopsy of the prostate as ordered by their doctor. During this prostate MRI-guided fusion biopsy, the research team will obtain tissue from up to two additional biopsy targets selected by the Risk Map DSS tool. Ultimately, the clinical radiologist will make the final decision on the targets to be biopsied.

Primary Outcome Measure

Decision Map Tool Compared to Oncologists [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Cancer Intake Team
1-855-702-8222
Aytekin Oto (PRINCIPAL_INVESTIGATOR)

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