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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorChanghai Hospital

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

400,000 Participants
are divided into 1 treatment group

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