Clinical Trial

Artificial Intelligence-powered Low-Dose Computed Tomography for Screening of Pancreatic Cancer

Study acronym: AI-LDCT-PC
Recruiting
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Summary
Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with early diagnosis crucial for improving survival. Due to the absence of effective screening methods, most patients are diagnosed at advanced stages. The population undergoing low-dose computed tomography (LDCT) screening significantly overlaps with those at high risk for PDAC; however, traditional imaging methods have limited sensitivity for detecting pancreatic lesions. This study utilizes the Pancreatic Cancer Detection with Artificial Intelligence (PANDA) system to enhance LDCT for pancreatic cancer screening in a prospective, multicenter, observational cohort. PANDA will analyze LDCT images, followed by a multidisciplinary team (MDT) reassessment of abnormal interpretations. Based on MDT evaluation, individuals will be recalled for further examination, placed under a personalized follow-up plan, or monitored for at least one year. The primary outcomes include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate, while secondary outcomes focus on early-stage cancers, resectable tumors, and safety indicators such as false positive rates and unnecessary procedures. This study aims to assess the effectiveness and safety of AI-assisted LDCT for PDAC detection, providing a practical solution for improving public health and enhancing early diagnostic capabilities.
Trial Details
NCT Number NCT07117045
Lead Sponsor Changhai Hospital
Collaborators: The Affiliated People's Hospital of Ningbo University, The Second Affiliated Hospital of Jiaxing University, Meinian Onehealth Healthcare Holdings Co., Ltd, Ruici Medical Examination Institution
Conditions Pancreatic Cancer, Intraductal Papillary Mucinous Neoplasm, High-grade Pancreatic Intraepithelial Neoplasia, PDAC - Pancreatic Ductal Adenocarcinoma, Mucinous Cystic Neoplasm
Enrollment 400,000 participants
Start Date 2025-08-15
Primary Completion 2030-12-30 (estimated)
Study Completion 2032-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-12