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

NCT ID: NCT06336694

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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peritoneal metastases

No intervention had been adminstered during treatment of patients.

surgery or diagnostic staging laparoscopy

Intervention Type 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)

without peritoneal metastases

No intervention had been adminstered during treatment of patients.

surgery or diagnostic staging laparoscopy

Intervention Type 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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Siya Shi

clinical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shi-Ting Feng, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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Shi Siya

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSUFAH2021-025

Identifier Type: -

Identifier Source: org_study_id

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