Status:
COMPLETED
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Prostate Cancer Diagnosis
Eligibility:
MALE
Phase:
NA
Brief Summary
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 o...
Detailed Description
In this prospective study, after referral for suspected prostate cancer, the patient is scanned with magnetic resonance imaging (MRI) in accordance with guidelines of the standardized healthcare pathw...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06000046
Start Date
December 20 2023
End Date
October 13 2024
Last Update
January 24 2025
Active Locations (1)
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1
St. Olav's University Hospital
Trondheim, Norway