RecruitingNCT06638866

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

Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer

Sponsor

Changhai Hospital

Enrollment

5,000 participants

Start Date

Aug 3, 2024

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Intraductal Papillary Mucinous Neoplasm Mucinous Cystic Neoplasm Pancreatic Intraepithelial Neoplasias

Summary

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

Min Age: 18 Years

Inclusion Criteria1

\. Individuals undergoing routine non-contrast chest and/or abdominal CT scans for non-pancreatic indications.

Exclusion Criteria4

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.

Interventions

DIAGNOSTIC_TESTPDAC

Participants with algorithm-identified PDAC will be independently reviewed by two radiologists. Those highly suspected will be recalled for further diagnostic evaluation, including serological tests (e.g., CA19-9, CEA) and imaging (e.g., contrast-enhanced CT/MRI, EUS-FNA). Participants with a confirmed positive diagnosis will undergo multidisciplinary consultation and specialized treatment, while those with a negative diagnosis will be followed clinically for at least one year.

DIAGNOSTIC_TESTPancreatic precursor lesions

Participants with algorithm-identified pancreatic precursor lesions will be independently reviewed by two radiologists. Those highly suspected will be recalled for further diagnostic evaluation, including serological tests (e.g., CA19-9, CEA) and imaging (e.g., contrast-enhanced CT/MRI, EUS-FNA). Participants with a confirmed positive diagnosis will undergo multidisciplinary consultation and specialized treatment, while those with a negative diagnosis will be followed clinically for at least one year.