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NCT07117045: AI-LDCT-PC
Artificial Intelligence-powered Low-Dose Computed Tomography for Screening of Pancreatic Cancer
trial testing Diagnostic Evaluation for Positive AI Findings in Pancreatic Cancer in 400,000 participants. Currently enrolling.
30 December 2030
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 400,000 |
| Start date | 15 August 2025 |
| Primary completion | 30 December 2030 |
| Estimated completion | 30 December 2032 |
| Sites | 5 locations across China |
Drugs / interventions tested
- Diagnostic Evaluation for Positive AI Findings
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
- Intraductal Papillary Mucinous Neoplasm — all drugs for Intraductal Papillary Mucinous Neoplasm →
- High-grade Pancreatic Intraepithelial Neoplasia — all drugs for High-grade Pancreatic Intraepithelial Neoplasia →
- PDAC - Pancreatic Ductal Adenocarcinoma — all drugs for PDAC - Pancreatic Ductal Adenocarcinoma →
Sponsor
Changhai Hospital
Who can join
50 and older, any sex, with Pancreatic Cancer or Intraductal Papillary Mucinous Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07117045
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07117045 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changhai Hospital
- Last refreshed: 12 August 2025
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