Actively Recruiting

Age: 50Years +
All Genders
Healthy Volunteers
ID07117045

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

Led by Changhai Hospital · Updated on 2025-08-12

400000

Participants Needed

5

Research Sites

104 weeks

Total Duration

On this page

Sponsors

C

Changhai Hospital

Lead Sponsor

T

The Affiliated People's Hospital of Ningbo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive cancer with a low 5-year survival rate, making early diagnosis vital to improving outcomes. Current screening methods are limited and often miss early-stage disease, especially for the general public. Researchers are evaluating the use of an Artificial Intelligence (AI) system called PANDA combined with low-dose computed tomography (LDCT) to enhance pancreatic cancer screening in a prospective, multicenter, observational cohort, aiming to improve early detection and reduce unnecessary procedures. Participants will undergo annual LDCT scans analyzed by the PANDA AI system. Abnormal findings identified by the AI are reviewed by a multidisciplinary team (MDT) to decide next steps: suspected pancreatic cancer or precursor lesions lead to hospital examinations; benign lesions receive personalized monitoring; and cases confirmed as normal by MDT will have at least one year of follow-up. If abnormalities appear during follow-up, participants will be managed accordingly. This approach focuses on evaluating detection rates, predictive values, consensus, and recall rates over two years. During the study, participants will complete LDCT exams and consent to follow-up assessments based on AI and MDT findings. Researchers will monitor pancreatic cancer detection rates, early-stage cancer proportions, and safety indicators like false positives and unnecessary invasive procedures. Follow-up will continue for at least one year for some participants, with ongoing monitoring to assess the effectiveness and safety of AI-assisted LDCT screening in a health check-up population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years and above
  • Voluntary signing of informed consent
  • Completion of low-dose computed tomography (LDCT) examination
Not Eligible

You will not qualify if you...

  • 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
  • Unable to complete follow-up due to physical or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

Duration - Up to 2 years

Participants undergo annual screening with the low-dose CT combined with AI system to detect pancreatic abnormalities.

Annual visits for screening

Diagnostic Evaluation

Duration - Varies depending on findings

For participants with positive AI findings, a multidisciplinary team reviews results to determine further steps including hospital examination or personalized monitoring.

1 to multiple visits depending on diagnostic needs

Long-term Monitoring

Duration - At least 1 year

Participants with benign lesions or confirmed normal pancreatic issues receive personalized monitoring for at least one year, with management adjusted if abnormalities arise.

Periodic visits based on monitoring plan

Trial Site Locations

Total: 5 locations

1

Meinian Onehealth Healthcare Holdings Co., Ltd

Shanghai, Shanghai Municipality, China, 200072

Actively Recruiting

2

Ruici Medical Examination Institution

Shanghai, Shanghai Municipality, China, 200126

Actively Recruiting

3

Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

4

Jiaxing University Affiliated Second Hospital

Jiaxing, Zhejiang, China, 314000

Actively Recruiting

5

Ningbo University Affiliated People's Hospital

Ningbo, Zhejiang, China, 315100

Actively Recruiting

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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

1

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Frequently Asked Questions

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Published Research Related To This Trial

Survival Prediction in Pancreatic Ductal Adenocarcinoma by Quantitative Computed Tomography Image Analysis.

Marc A Attiyeh, Jayasree Chakraborty, Alexandre Doussot...

https://pubmed.ncbi.nlm.nih.gov/29380093