Clinical trial · Interventional
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Radiation | — | UNRESOLVED |
| Magnetic Resonance Imaging (MRI) Guided Biopsy | Procedure | — | UNRESOLVED |
| Risk Map Decision Support System (DSS). | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Participants (Single Arm)
- description
- 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.
- interventionNames
- Other: Risk Map Decision Support System (DSS).
- Radiation: Magnetic Resonance Imaging (MRI)
- Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy
Primary outcomes (1)
- measure
- Decision Map Tool Compared to Oncologists
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available