Description

Pancreatic ductal adenocarcinoma (PDAC) is an extremely aggressive cancer with a dismal 5-year survival rate of just 13%. The key to improving outcomes lies in early detection, as patients diagnosed at an early stage (IA) can achieve an 80% 5-year survival. However, current screening methods are limited, focusing only on high-risk populations and lacking effectiveness for the general public due to the cancer's relatively low incidence and high false-positive risks.

Contrast-enhanced CT (CE-CT), the primary imaging modality, faces barriers for widespread implementation due to its invasiveness, high costs, and need for contrast agents. In this context, low-dose CT (LDCT) emerges as a promising alternative, having demonstrated success in lung cancer screening by reducing radiation exposure. Retrospective analysis revealed that one-third of pancreatic abnormalities were missed during routine LDCT interpretations, suggesting the untapped potential of LDCT-based pancreatic lesion screening.

Breakthroughs in AI have transformed medical imaging. Our PANDA (pancreatic cancer detection with artifcial intelligence) system excels at pancreatic cancer detection, utilizing innovative registration techniques and a cascaded deep learning framework (UNet+Max-Deeplab) for comprehensive lesion analysis. Validated across 10 centers (6,239 patients), PANDA outperformed radiologists. Real-world testing (20,530 cases) demonstrated remarkable accuracy: 92.9% sensitivity and 99.9% specificity, maintaining 92.2% sensitivity even for small T1 tumors. On LDCT, PANDA achieved 0.979 AUC without protocol modifications, confirming "LDCT+AI" as a viable screening approach.

China's health check-up environment presents three key advantages: First, LDCT delivers just 1/4-1/5 the radiation of standard abdominal CT, staying within ICRP safety guidelines (<3mSv). Second, LDCT offers superior cost-effectiveness compared to CE-CT by eliminating contrast agent expenses. Third, China's extensive annual health check-up infrastructure provides an unparalleled foundation for widespread implementation.

In the study, we will conduct a prospective, multicenter, observational cohort design targeting a health check-up population, utilizing the PANDA system to enhance LDCT for pancreatic cancer screening. Initially, PANDA analyzes the LDCT images of participants and provides interpretation results. Subsequently, a multidisciplinary team (MDT) will re-evaluate the cases with positive AI findings (including PDAC, pancreatic precursor lesions and benign lesion) and determine whether to recall the individuals: (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). The primary outcome measures include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate. Secondary outcome measures include the proportion of early-stage pancreatic cancers and resectable tumors. Safety indicators include the false positive rate, the proportion of unnecessary invasive procedures, and the proportion of unnecessary surgeries.

This study aims to evaluate the effectiveness and safety of AI-powered LDCT in detecting pancreatic cancer within a health check-up population, offering a practical solution to improve public health and early diagnosis for pancreatic cancer.