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Trial Title:
Research of the Application of Artificial Intelligence Model "PANDA"
NCT ID:
NCT06528223
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Artificial intelligence
Pancreatic cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study divides enrolled patients into three groups based on PANDA's output results:
nonPDAC, PDAC, and normal.
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
biopsy or operation
Description:
To obtain a biopsy pathology or surgical pathology according to the clinical process of
PDAC.
Arm group label:
PDAC
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
the First Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
the First Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Start date:
August 15, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528223
