MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Recruiting · NCT05710380 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →Interventions studied
Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) Guided BiopsyRisk Map Decision Support System (DSS).
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- University of Chicago Medicine Comprehensive Cancer Center - Chicago, Illinois, United States
- Oregon Health & Science University - Portland, Oregon, United States