RecruitingNCT07117045

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

Sponsor

Changhai Hospital

Enrollment

400,000 participants

Start Date

Aug 15, 2025

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer PDAC - Pancreatic Ductal Adenocarcinoma Intraductal Papillary Mucinous Neoplasm High-grade Pancreatic Intraepithelial Neoplasia Mucinous Cystic Neoplasm

Summary

Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with early diagnosis crucial for improving survival. Due to the absence of effective screening methods, most patients are diagnosed at advanced stages. The population undergoing low-dose computed tomography (LDCT) screening significantly overlaps with those at high risk for PDAC; however, traditional imaging methods have limited sensitivity for detecting pancreatic lesions. This study utilizes the Pancreatic Cancer Detection with Artificial Intelligence (PANDA) system to enhance LDCT for pancreatic cancer screening in a prospective, multicenter, observational cohort. PANDA will analyze LDCT images, followed by a multidisciplinary team (MDT) reassessment of abnormal interpretations. Based on MDT evaluation, individuals will be recalled for further examination, placed under a personalized follow-up plan, or monitored for at least one year. The primary outcomes include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate, while secondary outcomes focus on early-stage cancers, resectable tumors, and safety indicators such as false positive rates and unnecessary procedures. This study aims to assess the effectiveness and safety of AI-assisted LDCT for PDAC detection, providing a practical solution for improving public health and enhancing early diagnostic capabilities.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an artificial intelligence (AI) system can improve the detection of pancreatic cancer on low-dose CT (computed tomography) scans. The aim is to develop a more accurate and safer way to screen for pancreatic cancer, which is often caught too late. **You may be eligible if...** - You are 50 years or older - You voluntarily agree to participate - You are able to complete a low-dose CT scan **You may NOT be eligible if...** - You have a previous history of pancreatic cancer - You have had abdominal inflammation or acute pancreatitis in the past 6 months - Your CT scan quality would be poor due to fluid in the abdomen, recent surgery, or prior radiation/chemotherapy - You are unable to complete follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTDiagnostic Evaluation for Positive AI Findings

MDT will review positive AI findings (including PDAC, pancreatic precursor lesions and benign lesion) cases to determine next steps: (1) Suspected PDAC and pancreatic precursor lesions are referred for hospital examination with diagnostic results collected; (2) Benign lesion cases receive personalized monitoring until endpoint events or study end; (3) Cases with positive AI findings but MDT-confirmed normal pancreatic issues receive at least one year of follow-up. If any abnormal results arise, management will transition to either plan (1) or (2).