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Trial Title:
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
NCT ID:
NCT05710380
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Prostate Neoplasm
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Risk Map Decision Support System (DSS).
Description:
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.
Arm group label:
All Participants (Single Arm)
Intervention type:
Radiation
Intervention name:
Magnetic Resonance Imaging (MRI)
Description:
A medical imaging test that uses a large machine/scanner to take images of the body and
internal organs and structures.
Arm group label:
All Participants (Single Arm)
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging (MRI) Guided Biopsy
Description:
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.
Arm group label:
All Participants (Single Arm)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago Medicine Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Intake Team
Phone:
855-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Aytekin Oto
Email:
Principal Investigator
Start date:
April 26, 2023
Completion date:
May 1, 2026
Lead sponsor:
Agency:
University of Chicago
Agency class:
Other
Source:
University of Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05710380
