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
- Prostate Adenocarcinoma
- Prostate Cancer
- Prostate Neoplasm
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Risk Map Decision Support System (DSS). — OTHERThe 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 — PROCEDUREA 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
- Aytekin Oto, MD773-702-8553
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | 60637 | Aytekin Oto (PRINCIPAL_INVESTIGATOR) |
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