Research of the Application of Artificial Intelligence Model "PANDA"

Research of the Application of Artificial Intelligence Model 'PANDA': A MultiCenter, Prospective Randomized Controlled Clinical Trial

The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA, which was developed based on deep learning and plain CT scans in previous studies. This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University, leveraging clinical big data. The goal is to verify the model's role in suggesting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the groundwork for large-scale opportunistic screening of PDAC.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Diagnostic test: biopsy or operation

Detailed Description

This study focuses on potential cases of clinically missed PDAC. It aims to evaluate the pancreatic cancer screening model PANDA, based on deep learning and non-enhanced CT scans, in a prospective real-world cohort from multiple clinical scenarios at the First Affiliated Hospital of Zhejiang University. The study will track patients with negative imaging reports but positive PANDA model findings, verifying their pathology through gold standard examinations to assess PANDA's efficacy. It aims to validate the model's utility, applicability, sensitivity, and specificity.

Based on these objectives, the study will undertake the following:

1. Utilize PANDA's output to categorize enrolled patients into nonPDAC, PDAC, and normal groups. It will compare these results with imaging findings. Patients identified as PANDA-positive for PDAC but without corresponding imaging evidence of pancreatic lesions, or those with imaging suggesting pancreatic findings but lacking subsequent clinical intervention, will be categorized for follow-up. These patients will be recalled to the hospital for further examination and diagnosis at Zhejiang University's First Affiliated Hospital. For PDAC-positive cases identified during secondary examinations, standard clinical procedures such as MDT will be followed for confirmation of pathology. Patients identified as PDAC-negative during secondary examinations will undergo extensive follow-up for up to two years to determine outcomes, thus validating PANDA's sensitivity and specificity. Patients identified by PANDA as nonPDAC-positive but lacking corresponding pancreatic findings in imaging will undergo a review by hepatobiliary pancreatic surgeons to confirm accuracy. Those reported as normal by PANDA but with imaging suggesting pancreatic abnormalities will undergo secondary review by surgical experts to confirm or rule out false negatives by PANDA.
2. For true positive PDAC cases identified by PANDA, medical records will be collected (tumor marker levels, patient symptoms, resectability grading, TNM staging, etc.) for comparison with corresponding indicators from PDAC patients identified through the Standard Order of Clinic SOC. This aims to validate PANDA's capability in early detection and identification of lesions in pancreatic cancer development.

• Study Type: Interventional
• Enrollment (Estimated): 200000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Zhang, Associate professor; Phone Number: 13819137113; Email: qi.zhang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • the First Affiliated Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310009
      • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The participants have undergone chest and/or abdominal plain CT scans at outpatient, inpatient, or physical examination centers

Exclusion Criteria:

• Chest CT scan without pancreatic coverage
• Patients undergoing thoracic/abdominal surgical procedures that affect or alter the anatomical display of the pancreas (esophageal/gastric/pancreatic/vascular/ERCP postoperative, etc.)
• Scanning non-standard examinations, such as significant respiratory motion artifacts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDAC; According to the PANDA output results, those with the highest probability of PDAC among nonPDAC, PDAC, and normal categories are categorized into the PDAC group.	Diagnostic test: biopsy or operation; To obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC.
No Intervention: nonPDAC; According to the PANDA output results, those with the highest probability of nonPDAC among nonPDAC, PDAC, and normal categories are categorized into the nonPDAC group.
No Intervention: Normal; According to the PANDA output results, those with the highest probability of Normal among nonPDAC, PDAC, and normal categories are categorized into the Normal group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	From diagnosis of PDAC to 3 years later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNM stage	Staging of pancreatic cancer	1 day (evaluate through CT imaging before surgery)
Resectability grading	Resectability grading of pancreatic cancer	1 day (evaluate through CT imaging before surgery)
Tumor markers	Characteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells，like CA199	Immediately after recall

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Artificial intelligence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PANDA-PRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No