Viewing Study NCT06362291



Ignite Creation Date: 2024-05-06 @ 8:24 PM
Last Modification Date: 2024-10-26 @ 3:26 PM
Study NCT ID: NCT06362291
Status: RECRUITING
Last Update Posted: 2024-04-12
First Post: 2024-04-09

Brief Title: Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis a Prospective Randomized Controlled Trial
Sponsor: Peking University First Hospital
Organization: Peking University First Hospital

Study Overview

Official Title: Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis a Prospective Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-08
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: The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB AI-cTB and routine cTB and explore the added value of using AI for the guidance of cTB The main questions it aims to answer are

Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer Whats the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy Whats the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy

Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB

Participants will

Receive AI-cTB or routine cTB
Detailed Description: Cognitive fusion MRI-guided targeted biopsy cTB has been widely used in the diagnosis of prostate cancer PCa However cTB relies heavily on the operators experience and confidence in MRI readings The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB AI-cTB and routine cTB and explore the added value of using AI for the guidance of cTB

The main questions it aims to answer are

Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer Whats the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy Whats the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy

This prospective single-institution RCT compared the csPCa detection rates of the AI-cTB and routine cTB Participants were prospectively enrolled at Peking University First Hospital Beijing China from August 2023 to July 2024 Participants were randomly allocated to AI-cTB group and routine cTB group

Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB

Participants will

Receive AI-cTB or routine cTB

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None