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Validation of AI Imaging for Early Pancreatic Cancer: A Multicenter Study

Validation of an Artificial Intelligence-Based Imaging Algorithm for Early Pancreatic Cancer: A Multicenter Retrospective Study - Validation of an Artificial Intelligence-Based Imaging Algorithm for Early Pancreatic Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059076
Enrollment
400
Registered
2025-09-15
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

None listed

Sponsors

Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pancreatic cancer group: Patients diagnosed with pancreatic cancer with a primary tumor diameter of <=20 mm between January 1, 2014 and December 31, 2024. Pancreatic cancer is defined as either of the following: Histological diagnosis of adenocarcinoma of the pancreas. Histological diagnosis of pancreatic intraepithelial neoplasia grade 3 (PanIN-3)/high-grade PanIN. Subgroup: Tis/<=10 mm pancreatic cancer group Among the pancreatic cancer group, patients who meet all of the following: Diagnosed with pancreatic carcinoma in situ/PanIN-3/high-grade PanIN. Tumor size diagnosed as <=10 mm. Normal control group: Patients who underwent contrast-enhanced or non-contrast abdominal CT between January 1, 2014 and December 31, 2024 for the diagnosis of diseases other than pancreatic cancer, and who had no pancrea

Exclusion criteria

Exclusion criteria: Patients who requested not to participate in this study based on publicly available information Patients without pancreatic CT imaging data or with poor image quality that precludes evaluation Patients younger than 18 years (for cases prior to March 31, 2022, patients younger than 20 years)

Design outcomes

Primary

MeasureTime frame
Concordance between the presence or absence of pancreatic cancer as determined by the AI-based imaging algorithm and the definitive diagnosis based on the pathological findings.

Secondary

MeasureTime frame
Presence or absence of pancreatic cancer as determined by expert radiologists (pancreatic cancer present/pancreatic cancer absent) Detection of direct findings (tumor mass) by the AI-based imaging algorithm Detection of direct findings (tumor mass) by expert radiologists Detection of indirect findings (e.g., main pancreatic duct dilatation, localized pancreatic atrophy) by the AI-based imaging algorithm Detection of indirect findings (e.g., main pancreatic duct dilatation, localized pancreatic atrophy) by expert radiologists Presence or absence of pancreatic cancer in past imaging as determined by the AI-based imaging algorithm Presence or absence of pancreatic cancer in past imaging as determined by the reference standard (consensus of two expert radiologists)

Countries

Japan

Contacts

Public ContactAtsuhiro Masuda

Kobe University Graduate School of Medicine Division of Gastroenterology, Department of Internal Medicine

gastro@med.kobe-u.ac.jp+81-78-382-6305

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026