A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma

NCT06336694 | Completed

• 1 other identifier: SYSUFAH2021-025
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• diagnosed with peritoneal metastases

  percentage

  immediately after the surgery

Study Arms (2)

peritoneal metastases

No intervention had been adminstered during treatment of patients.

Procedure: surgery or diagnostic staging laparoscopy

without peritoneal metastases

No intervention had been adminstered during treatment of patients.

Procedure: surgery or diagnostic staging laparoscopy

Interventions

surgery or diagnostic staging laparoscopy PROCEDURE

diagnosis of PDAC with peritoneal examination based on the surgical (for tumors treated with surgery) or diagnostic staging laparoscopy findings (for tumors treated with radiotherapy/chemotherapy)

peritoneal metastases; without peritoneal metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected pancreatic tumors who had undergone contrast-enhanced CT and pathological examinations were screened at Center 1 between January 2012 and October 2022 and Center 2 between January 2014 and October 2021.

You may not qualify if:

• (a) pathologically diagnosed PDAC by pathology, (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) history of pancreatic surgery, (d) history of pancreatic malignancy, and (e) poor CT image quality that undermined peritoneal lesion assessment

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Shi Siya

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peritoneum metastases confirmed by pathology

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Shi-Ting Feng, MD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: March 29, 2024
• Study Start: January 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: July 30, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)