Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575361
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis a Real-World Prospective Diagnostic Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence MRI-AI in assisting the diagnosis of prostate cancer PCa The main questions it aims to answer are
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer Whats the capability of prostate MRI-AI in calculating the prostate volumn Whats the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy Whats the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists
Participants will
Receive combination of systematic biopsy and targeted biopsy
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer Whats the capability of prostate MRI-AI in calculating the prostate volumn Whats the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy Whats the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists
Participants will
Receive combination of systematic biopsy and targeted biopsy
Detailed Description:
In recent years there have been remarkable advancements in the field of artificial intelligence AI techniques particularly in the medical domain These AI techniques have demonstrated the ability to significantly enhance various medical tasks such as tumor detection classification and prognosis prediction Increasing evidence supports the ability of AI to facilitate precise diagnosis of PCa and assist in therapeutic decisions Compared with doctors AI has the potential to identify not only holistic tumor morphology but also task-specific and granular radiological patterns that cannot be detected by the naked eye Therefore AI has great potential to reduce inconsistencies between observers and improve diagnostic accuracy Previous AI studies at our institution have developed deep learning-based AI models trained on MR images that achieve good performance in the detection and localization of clinically significant prostate cancer csPCa Furthermore the trained AI algorithms were embedded into proprietary structured reporting software and radiologists simulated their real-life work scenarios to interpret and report the PI-RADS category of each patient using this AI-based software However the data is mostly retrospective The capability of detecting the suspicious lesions on MRI guiding the prostate targeted biopsy and optimizing the biopsy scheme warrants further investigation
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence MRI-AI in assisting the diagnosis of prostate cancer PCa The main questions it aims to answer are
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer Whats the capability of prostate MRI-AI in calculating the prostate volumn Whats the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy Whats the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists
Participants will
Receive combination of systematic biopsy and targeted biopsy
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence MRI-AI in assisting the diagnosis of prostate cancer PCa The main questions it aims to answer are
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer Whats the capability of prostate MRI-AI in calculating the prostate volumn Whats the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy Whats the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists
Participants will
Receive combination of systematic biopsy and targeted biopsy
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?:
None