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To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

RECRUITINGN/ASponsored by Chinese University of Hong Kong
Actively Recruiting
PhaseN/A
SponsorChinese University of Hong Kong
Started2024-06-14
Est. completion2027-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06360523

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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