Ignite Creation Date:
2025-12-18 @ 8:24 AM
Ignite Modification Date:
2025-12-23 @ 11:08 PM
Study NCT ID:
NCT06643715
Status:
None
Last Update Posted:
2025-11-24 00:00:00
First Post:
2024-10-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model "PANDAPro"
Sponsor:
None
Organization:
Study Overview
Official Title:
Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model 'PANDAPro': A Single-Center,Realworld Clinical Trial
Status:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 from March 1, 2024, to August 1, 2024, 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.
In the second round of real-world validation, patients with non-contrast CT scans from March 1, 2024, to August 1, 2024, 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: