Research of the Application of Artificial Intelligence Model "PANDA"

NCT06528223 | Not Yet Recruiting

• 1 other identifier: PANDA-PRO
• Study Type: interventional
• Target: 200,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

Artificial intelligence; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  From diagnosis of PDAC to 3 years later

Secondary Outcomes (3)

• TNM stage

  1 day (evaluate through CT imaging before surgery)

• Resectability grading

  1 day (evaluate through CT imaging before surgery)

• Tumor markers

  Immediately after recall

Study Arms (3)

PDAC

EXPERIMENTAL

According to the PANDA output results, those with the highest probability of PDAC among nonPDAC, PDAC, and normal categories are categorized into the PDAC group.

Diagnostic Test: biopsy or operation

nonPDAC

NO INTERVENTION

According to the PANDA output results, those with the highest probability of nonPDAC among nonPDAC, PDAC, and normal categories are categorized into the nonPDAC group.

Normal

NO INTERVENTION

According to the PANDA output results, those with the highest probability of Normal among nonPDAC, PDAC, and normal categories are categorized into the Normal group.

Interventions

biopsy or operation DIAGNOSTIC_TEST

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

PDAC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants have undergone chest and/or abdominal plain CT scans at outpatient, inpatient, or physical examination centers

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Qi Zhang, Associate professor

CONTACT

13819137113; qi.zhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 30, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (2)