PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients

NCT06000046 | Completed DMC

• 3 other identifiers: 479272CIV-NO-23-04-042915REK KULMU A # 479272
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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 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

Prostate Cancer Diagnosis

Keywords

Prostate; Magnetic Resonance Imaging; Artificial Intelligence; Machine Learning; Computer-Aided Diagnosis; Radiomics

Outcome Measures

Primary Outcomes (2)

• Feasibility of the software in prospective study in a relevant clinical environment.

  The percentage of occurrence of a technical problem in the investigational software that hinders its use is less than 10% across all subjects.

  Approximately 45 days. Actual time in clinic is approximately 1.5 hours.

• Safety of the software in prospective study in a relevant clinical environment.

  There are no death or serious harm associated with an adverse device effect (ADE) of the investigational software.

  Approximately 45 days. Actual time in clinic is approximately 1.5 hours.

Secondary Outcomes (1)

• Performance of the software in prospective study in a relevant clinical environment.

  Approximately 45 days. Actual time in clinic is approximately 1.5 hours.

Study Arms (1)

MRI for prostate cancer

EXPERIMENTAL

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.

Device: Automatic image analysis

Interventions

Automatic image analysis DEVICE

After referral for suspected prostate cancer, the patient is scanned with magnetic resonance imaging (MRI) in accordance with guidelines of the standardized healthcare pathway. For consenting patients, the images are interpreted in two ways: first, in the conventional manner, i.e., manually by a radiologist, to determine whether clinically significant cancer is suspected. If so, the radiologist will delineate the suspicious lesions. In the second approach, the software will perform the same task as the radiologist, but automatically. If either or both interpretations point to significant cancer, the patient will be sent for targeted biopsy sampling. Histopathologic evaluation of the samples will then determine whether significant cancer is present in each of the targeted lesions (delineated by the radiologist, software, or both).

MRI for prostate cancer

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olav's University Hospital

Trondheim, Norway

Location

Study Officials

• Tone Frost Bathen, Prof.

  Norwegian University of Science and Technology (NTNU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: December 20, 2023
• Primary Completion: October 13, 2024
• Study Completion: October 13, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

NO (1)