To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Chinese University of Hong Kong
368 participants
Jun 14, 2024
INTERVENTIONAL
Conditions
Summary
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
Eligibility
Inclusion Criteria4
- Patients recommended for prostate biopsy for diagnosis or re-assessment.
- Men at least 18 years or over
- Patients with prostate MRI image eligible for radiologist review and AI review.
- Patient Informed Consent is signed.
Exclusion Criteria2
- Patient contraindicated to prostate biopsy
- Patient failed to complete the biopsy procedure
Interventions
The MRI image will be reviewed by radiologist and AI model(s) respectively. The urologist will combine the results of the two approaches to optimize the biopsy strategy which is expected to result in more accurate diagnosis.
The MRI image will be reviewed by radiologist.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06360523