Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06638866

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

Led by Changhai Hospital · Updated on 2025-03-19

5000

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Changhai Hospital

Lead Sponsor

Y

Yinzhou Hospital Affiliated to Medical School of Ningbo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pancreatic ductal adenocarcinoma (PDAC) is a serious cancer with low 5-year survival rates, mainly due to late-stage diagnosis. Researchers are studying an AI-powered screening system that uses non-contrast computed tomography (NCCT) scans taken during routine medical visits or health check-ups. This observational, multi-center study aims to improve early detection of PDAC and its precursor lesions, potentially leading to better patient outcomes and wider access, especially in underserved areas. The study will use a deep learning AI model to automatically detect abnormalities in the pancreas from NCCT images. Cases flagged by the AI will be reviewed by two independent radiologists. If the radiologists suspect cancer or precursor lesions, participants will undergo further testing such as blood tests and advanced imaging. Those diagnosed with PDAC or precursor lesions will receive specialized treatment and consultation, while those without a diagnosis will be followed clinically for at least one year. Participants will be involved through routine CT scans without additional imaging initially. The study will measure the AI system's accuracy by tracking detection rates, recall rates for further testing, and positive predictive value over three years. Secondary outcomes include the proportion of early-stage PDAC detected and survival time over five years. The study involves multiple hospitals and technical support, with ongoing monitoring and clinical follow-up for confirmed or negative cases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals undergoing routine non-contrast chest and/or abdominal CT scans for non-pancreatic reasons
  • Aged 18 years or older
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during routine non-contrast chest and/or abdominal CT scans

Diagnostic Evaluation

Duration - Up to several weeks depending on diagnostic process

Participants with AI-identified pancreatic cancer or precursor lesions undergo further diagnostic evaluation including serological tests and imaging studies to confirm diagnosis.

1 to 2 visits depending on diagnostic testing required

Long-term Monitoring

Duration - At least 1 year

Participants with a negative diagnosis after confirmatory testing are clinically followed for at least one year to monitor pancreatic health.

Regular follow-up visits during clinical monitoring

Trial Site Locations

Total: 3 locations

1

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

2

Second Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China, 314000

Actively Recruiting

3

Yinzhou Hospital Affiliated to Medical School of Ningbo University

Ningbo, Zhejiang, China, 315100

Actively Recruiting

Loading map...

Research Team

W

Wang Bei Lei, M.D.

G

Guo Shi Wei, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Prediagnostic Image Data, Artificial Intelligence, and Pancreatic Cancer: A Tell-Tale Sign to Early Detection.

Matthew R Young, Natalie Abrams, Sharmistha Ghosh...

https://pubmed.ncbi.nlm.nih.gov/32675784

Pancreatic Cancer: Changing Epidemiology and New Approaches to Risk Assessment, Early Detection, and Prevention.

Elena M Stoffel, Randall E Brand, Michael Goggins

https://pubmed.ncbi.nlm.nih.gov/36804602

Screening for Pancreatic Cancer: US Preventive Services Task Force Reaffirmation Recommendation Statement.

US Preventive Services Task Force, Douglas K Owens, Karina W Davidson...

https://pubmed.ncbi.nlm.nih.gov/31386141