Clinical trial · Interventional
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients
A Proof-of-technology, Pilot, Prospective Clinical Study to Investigate the Feasibility and Performance of PROVIZ-a Radiomics-based Machine Learning Software, to Support Targeting of Prostate Biopsies on MRI Images in Biopsy-naive Patients
- 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)
To perform a traditional feasibility clinical investigation, as defined in ISO 14155:2020, to investigate preliminary feasibility, safety, and clinical performance information of a near-final design of the investigational software. This will be performed through a prospective clinical study on biopsy naïve men with suspected prostate cancer examined with MRI at St. Olavs Hospital, Trondheim, Norway, in order to adequately plan an appropriate pivotal clinical investigation.
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 Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automatic image analysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI for prostate cancer
- description
- Biopsy-naive men undergoing MRI for suspected prostate cancer via the Norwegian standardized care pathway. The MRI images will then be evaluated by the radiologist and a machine-learning based diagnosis and detection system.
- interventionNames
- Device: Automatic image analysis
Primary outcomes (2)
- measure
- Feasibility of the software in prospective study in a relevant clinical environment.
- timeFrame
- Approximately 45 days. Actual time in clinic is approximately 1.5 hours.
- description
- The percentage of occurrence of a technical problem in the investigational software that hinders its use is less than 10% across all subjects.
- measure
- Safety of the software in prospective study in a relevant clinical environment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Biopsy-naive men undergoing MRI examination for suspected prostate cancer via the Norwegian standardized care pathway. * Patients who give consent to participate during the enrollment period. Exclusion Criteria: * Patients who have undergone a biopsy for prostate cancer in the past 3 years. * Patients who currently enrolled in an active surveillance program for prostate cancer. * Patients who have had hip replacements that may affect the quality of the image. * Patients with claustrophobia. * Patients who intolerance to glucagon or buscopan. * Patients who unable to sign the informed consent themselves.
References
Publications (0)
Data not yet available