Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643715
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model PANDA PLUS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model PANDA PLUS a MultiCenter Prospective Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This study aims to utilize large-scale real-time CTComputed Tomography imaging data from multiple centers and scenarios including the First Affiliated Hospital of Zhejiang University Lishui Central Hospital and the Second Affiliated Hospital of Nanchang University within a prospective real-world cohort Radiologists will be stratified by years of experience and randomly assigned into two groups The experimental group will use PANDAPancreatic Cancer Detection with Artificial Intelligence Plus results to assist in generating imaging reports The study will record the radiologists interpretations before and after reviewing the PANDA Plus reports and will track patients with imaging reports suggesting suspicion of PDACPancreatic ductal adenocarcinoma positivity from both groups Follow-up will be conducted to verify whether patients with negative imaging reports in both groups develop pancreatic cancer The study will assess the benefit of PANDA Plus in assisting clinical radiologists in diagnosing PDAC under non-contrast CT conditions It will compare the sensitivity specificity and positive predictive value of PDAC detection with and without the assistance of the PANDA Plus model as well as differences in the initial TNM staging resectability rates and long-term survival data
Detailed Description:
This study aims to utilize large-scale real-time imaging data from multiple centers including the First Affiliated Hospital of Zhejiang University Lishui Central Hospital and the Second Affiliated Hospital of Nanchang University within a prospective real-world cohort Radiologists will be stratified by years of experience and randomly assigned into two groups One group will use the pancreatic cancer screening model PANDA PLUS while the other will use a pseudo-PANDA model to assist in diagnosis during routine clinical practice Both groups will be tracked for cases with imaging reports suggesting possible PDAC positivity and follow-up will verify the final outcomes of patients with negative imaging reports Patients with positive reports will receive regular follow-up every three months to obtain clinical history pathological gold standards initial tumor markers resectability classification TNM staging and long-term survival data The study will evaluate the effectiveness of PANDA PLUS in assisting clinical radiologists in diagnosing PDAC under non-contrast CT conditions and compare the sensitivity specificity and positive predictive value of PDAC detection between the pseudo-PANDA and PANDA PLUS models Additionally it will compare differences in initial TNM staging resectability rates and long-term survival data The study will also assess the detection efficiency of PANDA PLUS for triple-negative PDAC negative clinical symptoms negative tumor markers and negative non-contrast CT imaging
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