NCT06000046Completed
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 · Last updated 24 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 14 Aug 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 13 Oct 2024
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT06000046
What you commit to
- Study type: Interventional
- Participants enrolled: 82
- From 20 Dec 2023 to the primary completion date, 13 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Olav's University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.