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NCT Number: NCT06528223

Research of the Application of Artificial Intelligence Model "PANDA"

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biopsy or operation

Diagnostic Test

To obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC.

Primary outcomes

  1. OS

    Time frame: From diagnosis of PDAC to 3 years later

    overall survival

Secondary outcomes

  1. TNM stage

    Time frame: 1 day (evaluate through CT imaging before surgery)

    Staging of pancreatic cancer

  2. Resectability grading

    Time frame: 1 day (evaluate through CT imaging before surgery)

    Resectability grading of pancreatic cancer

  3. Tumor markers

    Time frame: Immediately after recall

    Characteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells,like CA199

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Zhang, Associate professor

CONTACT

[email protected]

13819137113

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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