Clinical trial · Interventional
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
NCT03585660CI-TRIAL-00080574completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
Conditions
Conditions (1)
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic MRI | Procedure | — | UNRESOLVED |
| Diagnostic Prostate Biopsy | Procedure | — | UNRESOLVED |
| Risk Map DSS tool | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional Arm
- description
- Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
- interventionNames
- Procedure: Diagnostic MRI
- Procedure: Diagnostic Prostate Biopsy
- Device: Risk Map DSS tool
Primary outcomes (2)
- measure
- Accuracy of HM-MRI
- timeFrame
- 12 months
- description
- The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
- measure
- Area Under the ROC Curve (AUC) of HM-MRI
- timeFrame
- 12 months
- description
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 to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate. * Written informed consent. Exclusion Criteria: * Patients incapable of giving informed written consent; * Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher; * Patients 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).
References
Publications (1)
- DERIVEDChatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156. PMID 39836080