Pancreatic CancerNCT06643715
Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model "PANDAPro"
A study testing PANDA Pro in people with Pancreatic Cancer, run by Zhejiang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- PANDA Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- PANDA Pro
- Keywords
- Artificial Intelligence, Pancreatic Cancer, PANDA PLUS, PANDA
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANDA ProDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PANDA Pro | Experimental | recall of clinically missed but PANDA Pro detected pancreatic lesions Receives: Device: PANDA Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection efficiency of doctors in pancreatic cancer assisted by PANDA Pro
Sensitivity、Specificity、PPV、NPV
Measured: 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 outcomes (2)
TNM stage
Staging of pancreatic cancer
Measured: 1 day (evaluate through CT imaging before surgery)
Resectability grading
Resectability grading of pancreatic cancer
Measured: 1 day (evaluate through CT imaging before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start7 Mar 2026
- Primary completion18 May 2026
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The PANDA (Pancreatic Cancer Detection with Artificial Intelligence) early screening model was developed by Alibaba DAMO Academy.It employs a fully automated pancreatic segmentation model using the VoxelMorph algorithm, which enhances registration speed and accuracy. By building a self-learning framework, the model efficiently obtains precise annotations of non-contrast CT images. The core network is based on Transformer technology, combined with the MaskFormer model to improve diagnostic accuracy. The upgraded PANDA Pro model has improved upon the original PANDA model by enhancing its ability to differentiate between pancreatitis, pancreatic cystic lesions, and eliminating interference from adjacent organs such as the common bile duct and duodenum. These advancements have effectively increased the model's clinical utility, making it more reliable for real-world applications in diagnosing pancreatic conditions.
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Lishui Municipal Central Hospital, Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643715
- Sponsor's protocol ID
- ZY-PANDAPro
- Status last verified
- Feb 2026
- First submitted
- 10 Oct 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model 'PANDAPro': A Single-Center,Realworld Clinical Trial
- ClinicalTrials.gov ID
- NCT06643715
- Acronym / sponsor ID
- ZY-PANDAPro
- Conditions
- Pancreatic Cancer
- Keywords
- Artificial Intelligence, Pancreatic Cancer, PANDA PLUS, PANDA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Lishui Municipal Central Hospital, Second Affiliated Hospital of Nanchang University
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The PANDA (Pancreatic Cancer Detection with Artificial Intelligence) early screening model was developed by Alibaba DAMO Academy.It employs a fully automated pancreatic segmentation model using the VoxelMorph algorithm, which enhances registration speed and accuracy. By building a self-learning framework, the model efficiently obtains precise annotations of non-contrast CT images. The core network is based on Transformer technology, combined with the MaskFormer model to improve diagnostic accuracy. The upgraded PANDA Pro model has improved upon the original PANDA model by enhancing its ability to differentiate between pancreatitis, pancreatic cystic lesions, and eliminating interference from adjacent organs such as the common bile duct and duodenum. These advancements have effectively increased the model's clinical utility, making it more reliable for real-world applications in diagnosing pancreatic conditions.
| Arm | Type | Receives |
|---|---|---|
| PANDA Pro | Experimental | Device: PANDA Prorecall of clinically missed but PANDA Pro detected pancreatic lesions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PANDA ProPatients 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. | Device | PANDA Pro |
Primary outcome
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
2 secondary outcomes
TNM stage
Time frame: 1 day (evaluate through CT imaging before surgery)
Resectability grading
Time frame: 1 day (evaluate through CT imaging before surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PANDA Pro in people with Pancreatic Cancer, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.