MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Prostate Cancer Clinical Trial

Official title:

Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710380
• Other study ID #: IRB22-1311
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2023
• Source: University of Chicago
• Contact: Aytekin Oto, MD
• Phone: 773-702-8553
• Email: aoto[@]radiology.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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 prostate cancer.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Other:
• Risk Map Decision Support System (DSS).
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.

Radiation:
• Magnetic Resonance Imaging (MRI)
A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.

Procedure:
• Magnetic Resonance Imaging (MRI) Guided Biopsy
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.

Locations

Country	Name	City	State
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year