About this trial
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.
Eligibility criteria
Qualifiers
Age 50 years and above.
Voluntary signing of informed consent.
Completion of LDCT examination.
Disqualifiers
Previous history of pancreatic cancer.
Abdominal inflammation or diagnosis of acute pancreatitis within 6 months.
Poor image quality due to ascites, pancreatic trauma, thoracic/abdominal surgery, radiotherapy or chemotherapy.
Research subjects unable to complete follow-up due to physical or other reasons.
Trial design
Treatments tested in this trial
- Diagnostic Evaluation for Positive AI Findings
Treatment groups
Sponsors and collaborators
Changhai Hospital
Lead sponsor
The Affiliated People's Hospital of Ningbo University
Collaborator
Jiaxing University Affiliated Second Hospital
Collaborator
Meinian Onehealth Healthcare Holdings Co., Ltd
Collaborator
Ruici Medical Examination Institution
Collaborator