To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Recruiting · NCT06360523 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Patient contraindicated to prostate biopsy
- Patient failed to complete the biopsy procedure
Where it is running
1 location listed.
- Prince of Wales Hospital, Chinese University of Hong Kong - Hong Kong, Hong Kong