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NCT06336694 Clinical Trial

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

Pancreatic Neoplasms Clinical Trial

Official title:
Development and Validation of a Deep Learning Radiomics Model With Clinical-radiological Characteristics for the Identification of Occult Peritoneal Metastases in Patients With Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06336694
Other study ID # SYSUFAH2021-025
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date July 30, 2023

Study information
Verified date March 2024
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

This retrospective, bicentric study included 302 patients with PDAC (training: n = 167, OPM-positive, n=22; internal test: n = 72, OPM-positive, n=9: external test, n=63, OPM-positive, n=9) who had undergone baseline CT examinations between January 2012 and October 2022. Handcrafted radiomics (HCR) and DLR features of the tumor and HCR features of peritoneum were extracted from CT images. Mutual information and least absolute shrinkage and selection operator algorithms were used for feature selection. A combined model, which incorporated the selected clinical-radiological, HCR, and DLR features, was developed using a logistic regression classifier using data from the training cohort and validated in the test cohorts.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date July 30, 2023
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients with suspected pancreatic tumors who underwent contrast enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study. Exclusion Criteria: - (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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery or diagnostic staging laparoscopy
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)

Locations
Country Name City State
China Shi Siya Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosed with peritoneal metastases percentage immediately after the surgery
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