Artificial Intelligence-powered Low-Dose Computed Tomography for Screening of Pancreatic Cancer
Recruiting · NCT07117045 · Observational (researchers observe without assigning treatment) · Lead sponsor: Changhai Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age 50 years and above.
- Voluntary signing of informed consent.
- Completion of LDCT examination.
Exclusion criteria
- Previous history of pancreatic cancer.
- Abdominal inflammation or diagnosis of acute pancreatitis within 6 months.
- Poor image quality due to ascites, pancreatic trauma, thoracic/abdominal surgery, radiotherapy or chemotherapy.
- Research subjects unable to complete follow-up due to physical or other reasons.
Where it is running
5 locations listed.
- Meinian Onehealth Healthcare Holdings Co., Ltd - Shanghai, Shanghai Municipality, China
- Ruici Medical Examination Institution - Shanghai, Shanghai Municipality, China
- Changhai Hospital - Shanghai, Shanghai Municipality, China
- Jiaxing University Affiliated Second Hospital - Jiaxing, Zhejiang, China
- Ningbo University Affiliated People's Hospital - Ningbo, Zhejiang, China