Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059076) titled 'Validation of AI Imaging for Early Pancreatic Cancer: A Multicenter Study' on Sept. 15.

Study Type: Observational

Primary Sponsor: Institute - Kobe University

Condition: Condition - Pancreatic cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to validate the diagnostic performance of an artificial intelligence (AI)-based imaging algorithm for the early detection of pancreatic cancer. Using contrast-enhanced and non-contrast CT images from patients with pancreatic cancer and from normal controls, the established AI algorithm will be applied to assess its accuracy, sensitivity, and specificity. This study aims to clarify whether the AI system can serve as a reliable screening tool for detecting pancreatic cancer at an early stage, which may ultimately contribute to improved patient prognosis. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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) Target Size - 400

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 30 Day Date of IRB - 2025 Year 07 Month 30 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067571

Disclaimer: Curated by HT Syndication.