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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528223
Enrollment
200000
Registered
2024-07-30
Start date
2024-08-15
Completion date
2027-12-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Artificial intelligence, Pancreatic cancer

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTbiopsy or operation

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

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Intervention model description

The study divides enrolled patients into three groups based on PANDA's output results: nonPDAC, PDAC, and normal.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
OSFrom diagnosis of PDAC to 3 years lateroverall survival

Secondary

MeasureTime frameDescription
TNM stage1 day (evaluate through CT imaging before surgery)Staging of pancreatic cancer
Resectability grading1 day (evaluate through CT imaging before surgery)Resectability grading of pancreatic cancer
Tumor markersImmediately after recallCharacteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells,like CA199

Countries

China

Contacts

Primary ContactQi Zhang, Associate professor
qi.zhang@zju.edu.cn13819137113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026