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OpenTrials
Completed

NCT Number: NCT06336694

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shi Siya

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. diagnosed with peritoneal metastases

    Time frame: immediately after the surgery

    percentage

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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