Ignite Creation Date:
2025-12-18 @ 8:17 AM
Ignite Modification Date:
2025-12-18 @ 8:17 AM
Study NCT ID:
NCT06360523
Status:
None
Last Update Posted:
2025-05-06 00:00:00
First Post:
2024-04-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Sponsor:
None
Organization:
Study Overview
Official Title:
ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Status:
None
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: