Artificial Intelligence-powered Low-Dose Computed Tomography for Screening of Pancreatic Cancer
NCT07117045 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400000
Last updated 2025-08-12
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.
Conditions
- Pancreatic Cancer
- Intraductal Papillary Mucinous Neoplasm
- High-grade Pancreatic Intraepithelial Neoplasia
- PDAC - Pancreatic Ductal Adenocarcinoma
- Mucinous Cystic Neoplasm
Interventions
- DIAGNOSTIC_TEST
-
Diagnostic Evaluation for Positive AI Findings
MDT will review positive AI findings (including PDAC, pancreatic precursor lesions and benign lesion) cases to determine next steps: (1) Suspected PDAC and pancreatic precursor lesions are referred for hospital examination with diagnostic results collected; (2) Benign lesion cases receive personalized monitoring until endpoint events or study end; (3) Cases with positive AI findings but MDT-confirmed normal pancreatic issues receive at least one year of follow-up. If any abnormal results arise, management will transition to either plan (1) or (2).
Sponsors & Collaborators
-
Ningbo University Affiliated People's Hospital
collaborator UNKNOWN -
Jiaxing University Affiliated Second Hospital
collaborator UNKNOWN -
Meinian Onehealth Healthcare Holdings Co., Ltd
collaborator UNKNOWN -
Ruici Medical Examination Institution
collaborator UNKNOWN -
Changhai Hospital
lead OTHER
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2030-12-30
- Completion
- 2032-12-30
Countries
- China
Study Locations
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