Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392737
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-26
Brief Title:
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis
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 Multicenter Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this multicenter 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 Whats the generalizability of the MRI artificial intelligence assistant diagnosis system
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
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 Whats the generalizability of the MRI artificial intelligence assistant diagnosis system
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 Our previously single-center RCT has demonstrated the effectiveness of accurately detecting clinically significant PCa csPCa 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 This multicenter RCT aims to further validate the ability of MRI artificial intelligence in different institutions and investigate the generalizability of the MRI artificial intelligence assistant diagnosis system
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 Whats the generalizability of the MRI artificial intelligence assistant diagnosis system This multicenter RCT compared the csPCa detection rates of the AI-cTB and routine cTB Participants were prospectively enrolled at Peking University First Hospital Beijing China Beijing Miyun District Hospital Beijing China and Shanghai East Hospital Shanghai China from May 2024 to April 2025
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
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 Whats the generalizability of the MRI artificial intelligence assistant diagnosis system This multicenter RCT compared the csPCa detection rates of the AI-cTB and routine cTB Participants were prospectively enrolled at Peking University First Hospital Beijing China Beijing Miyun District Hospital Beijing China and Shanghai East Hospital Shanghai China from May 2024 to April 2025
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