Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model "PANDAPro"

June 3, 2026 updated by: TingBo Liang, Zhejiang University

Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model 'PANDAPro': A Single-Center,Realworld Clinical Trial

The purpose of this study is to build upon the previously developed deep learning-based non-contrast CT pancreatic cancer screening model, PANDA. The model will first undergo training and enhancement, followed by external validation across multiple centers. Subsequently, a large-scale real-world validation will be conducted at Zhejiang University's First Affiliated Hospital , the study will be divided into two rounds. In the first round, the performance of the PANDA model and the upgraded PANDA Pro model will be compared on consecutive retrospective real-world CT scans. In the second round, physicians will record the PANDA Pro results in real time to identify potential pancreatic lesions that may have been clinically missed. By leveraging clinical big data across different scenarios at Zhejiang University's First Affiliated Hospital, the study aims to validate the model's role in prompting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the foundation for large-scale opportunistic screening of PDAC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the first round of real-world validation, abdominal enhanced CT imaging data from patients treated at the First Affiliated Hospital of Zhejiang University between January 2018 and July 2022 were consecutively included. The results of both PANDA and PANDA Pro were recorded and compared with the pathological gold standard of the patients to evaluate model performance.

In the second round of real-world validation, patients with non-contrast CT scans are expected to be enrolled. The enrolled patients will be categorized into three groups: nonPDAC, PDAC, and normal. The results will be compared with imaging report findings. Patients with PANDA Pro-reported PDAC positivity but no pancreatic lesions indicated in the imaging report, or those with positive pancreatic findings in the imaging report but no subsequent clinical intervention, will be identified as requiring follow-up. These patients will be recalled to the First Affiliated Hospital of Zhejiang University for further examination and diagnosis. Among them, patients with secondary examination confirming PDAC positivity will undergo standard clinical procedures such as MDT at the hospital, ultimately tracking their treatment to confirm ground truth. For patients with secondary examination indicating PDAC negativity, a preliminary determination of their true status will be made after a small-scale discussion between hepatobiliary surgeons and radiologists. Those judged as false positives will undergo follow-up for up to two years to determine their outcomes, thereby validating the sensitivity and specificity of the PANDA Pro model. For patients with PANDA Pro-reported nonPDAC positivity but no positive pancreatic findings in the imaging report, hepatobiliary-pancreatic surgeons and radiologists will retrospectively review the images to confirm their true status. For patients with PANDA Pro-reported normal results but imaging reports indicating pancreatic lesions, a secondary review by surgeons will be conducted to determine whether it is a false negative by PANDA Pro.

For patients reported as true positives for PDAC by the PANDA Pro model, medical records (including tumor marker levels, patient symptoms, resectability classification, TNM staging, etc.) will be collected. These will be compared with corresponding indicators from PDAC patients identified through the SOC(Standard Order of Clinic) during the same period, to validate PANDA Pro's ability to detect and identify lesions in the early stages of pancreatic cancer development.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects who have undergone chest and/or abdominal CT scans at outpatient clinics, inpatient departments, or physical examination centers;
  • Age at the time of the scan between 18-90 years old, with no restriction on gender;

Exclusion Criteria:

  • Chest CT scans that do not cover the pancreas;
  • Patients who have undergone thoracic/abdominal surgeries affecting or altering the anatomical display of the pancreas (e.g., post-esophageal, gastric, pancreatic, vascular surgeries, or post-ERCP);
  • Non-standard scans (e.g., hands placed on either side of the body or abdomen, severe respiratory motion artifacts, perfusion contamination, etc.);
  • Patients referred to a higher-level hospital due to a pancreatic mass found during local hospital examination;
  • Patients who, for personal reasons, did not follow up with pancreatic cancer diagnosis or treatment at the hospital, or were lost to follow-up midway;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PANDA Pro
recall of clinically missed but PANDA Pro detected pancreatic lesions
Device: PANDA Pro
Patients with PANDA Pro-reported PDAC positivity but no pancreatic lesions indicated in the imaging report, or those with positive pancreatic findings in the imaging report but no subsequent clinical intervention, will be identified as requiring follow-up. These patients will be recalled to the First Affiliated Hospital of Zhejiang University for further examination and diagnosis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection efficiency of doctors in pancreatic cancer assisted by PANDA Pro
Time Frame: Complete the statistics within six months after the patient is fully enrolled, and it is expected to take 2 years from the start of the study
Sensitivity、Specificity、PPV、NPV
Complete the statistics within six months after the patient is fully enrolled, and it is expected to take 2 years from the start of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TNM stage
Time Frame: 1 day (evaluate through CT imaging before surgery)
Staging of pancreatic cancer
1 day (evaluate through CT imaging before surgery)
Resectability grading
Time Frame: 1 day (evaluate through CT imaging before surgery)
Resectability grading of pancreatic cancer
1 day (evaluate through CT imaging before surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Second Affiliated Hospital of Nanchang University
Lishui Municipal Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZY-PANDAPro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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