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

NCT07117045 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400000

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Diagnostic 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).

Sponsors & Collaborators

  • Ningbo University Affiliated People's Hospital

    collaborator UNKNOWN
  • Jiaxing University Affiliated Second Hospital

    collaborator UNKNOWN
  • Meinian Onehealth Healthcare Holdings Co., Ltd

    collaborator UNKNOWN
  • Ruici Medical Examination Institution

    collaborator UNKNOWN
  • Changhai Hospital

    lead OTHER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2030-12-30
Completion
2032-12-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117045 on ClinicalTrials.gov