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To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence - Trial NCT06360523

Access comprehensive clinical trial information for NCT06360523 through Pure Global AI's free database. This phase not specified trial is sponsored by Chinese University of Hong Kong and is currently Not yet recruiting. The study focuses on Prostate Cancer. Target enrollment is 102 participants.

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NCT06360523
Not yet recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06360523
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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

Study Focus

Prostate Cancer

AI modal

Observational

diagnostic test

Sponsor & Location

Chinese University of Hong Kong

Hong Kong, China

Timeline & Enrollment

N/A

May 01, 2024

Jul 20, 2025

102 participants

Primary Outcome

Prostate Cancer detection rate of ISUP grade group โ‰ฅ2

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 102 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.

ICD-10 Classifications

Malignant neoplasm of prostate
Hyperplasia of prostate
Disorder of prostate, unspecified
Other disorders of prostate
Carcinoma in situ: Prostate

Data Source

ClinicalTrials.gov

NCT06360523

Non-Device Trial