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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

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

Locations
Other Locations
China
Second Affiliated Hospital of Jiaxing University
RECRUITING
Jiaxing
Yinzhou Hospital Affiliated to Medical School of Ningbo University
RECRUITING
Ningbo
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Wang Bei Lei, M.D.
lilly_wang@126.com
86-13774238083
Backup
Guo Shi Wei, M.D.
gestwa@163.com
86-18621500666
Time Frame
Start Date: 2024-08-03
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 5000
Treatments
AIgorithm-classified PDAC Group
Participants who underwent non-contrast abdominal and/or chest CT scans and were preliminarily classified by the aIgorithm as PDAC.
AIgorithm-classified Pancreatic Precursor Lesions Group
Participants who underwent non-contrast abdominal and/or chest CT scans and were preliminarily classified by the aIgorithm as pancreatic precursor lesions.
Related Therapeutic Areas
Sponsors
Collaborators: Yinzhou Hospital Affiliated to Medical School of Ningbo University, Jingning County People's Hospital, Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Alibaba DAMO Academy
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov