AI-powered Early Detection for Pancreatic Cancer Via Non-contrast CT in Opportunistic Screening Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChanghai Hospital

About this trial

Pancreatic ductal adenocarcinoma (PDAC) remains a therapeutic challenge with 5-year survival rates of 13%, primarily attributable to advanced-stage diagnosis (AJCC Stage III/IV in \>80% of cases). This prospective, observational, multi-center study will evaluate the performance of an AI-powered opportunistic screening system utilizing non-contrast computed tomography (NCCT) acquired during routine clinical encounters or health check-ups. The proposed AI model will perform automated detection of pancreatic parenchymal abnormalities, including PDAC and precursor lesions (intraductal papillary mucinous neoplasms \[IPMN\], mucinous cystic neoplasms \[MCN\]). Algorithm-positive cases will be independently reviewed by two radiologists. Highly suspected individuals will undergo further diagnostic verification, including serological tests and multimodal imaging confirmation. Patients with confirmed positive diagnosis will receive multidisciplinary consultation and specialized treatment, whereas those with negative results will undergo at least one-year clinical follow-up. This study will quantitatively evaluate the AI system's performance, and aims to advance PDAC early detection, improve patient outcomes, and make it accessible in underserved populations.

Eligibility criteria

Qualifiers

None

Disqualifiers

History of pancreatic cancer;

History of thoracic or abdominal surgery;

Acute pancreatitis within 6 months;

Patients referred for evaluation of suspected or confirmed pancreatic cancer.

Trial design

Treatments tested in this trial

  • PDAC
  • Pancreatic precursor lesions

Treatment groups

5,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Changhai Hospital

Lead sponsor

Yinzhou Hospital Affiliated to Medical School of Ningbo University

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator

Central Hospital of Lishui City

Collaborator

Jingning County People's Hospital

Collaborator

Alibaba DAMO Academy

Collaborator