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Clinical Trials/NCT03872362
NCT03872362
Completed
Not Applicable

Radiomics and Clinical Variables Can Differentiate Malignant Nodules and Detect Invasive Adenocarcinoma in Pulmonary Nodules: a Multi-center Study

Maastricht University1 site in 1 country800 target enrollmentJuly 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Neoplasms
Sponsor
Maastricht University
Enrollment
800
Locations
1
Primary Endpoint
Malignant nodules classifier
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The investigators aim to investigate the utility of radiomics to differentiate malignant nodules from benign nodules and invasive adenocarcinoma from non-invasive adenocarcinoma.

Detailed Description

With the development of computed tomography (CT) equipment and the increasing use of lung cancer screening programs with low-dose CT, a growing number of early-stage lung cancers were detected so that a large number of patients have undergone surgery. Although a number of radiological studies have been used morphological signs so-called semantic features to make a differential diagnosis, it is still hard to apply by clinician because pulmonary nodules especially ground-glass nodules and small size nodules have atypical radiology signs and have strong subjectivity from different observers. Recently, CT-based radiomics, extracting the quantitative high-throughput features from medical images and facilitating clinical decision-making system, showed a good performance to predict diagnosis and prognosis of diverse cancer. Therefore, the proposed project aims to develop and validate radiomics models based on CT images to identify malignant nodules and then to discriminate the different types of lung adenocarcinoma in patients with pulmonary nodules.

Registry
clinicaltrials.gov
Start Date
July 11, 2018
End Date
February 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • intraoperative frozen section diagnosis and final pathology diagnosis are available
  • preoperative standard non-enhanced CT is available
  • Pathologically confirmed

Exclusion Criteria

  • with a previous history of radiation therapy, chemotherapy or biopsy
  • the time interval between the CT examination and surgery was more than two weeks

Outcomes

Primary Outcomes

Malignant nodules classifier

Time Frame: 30 days

Model based on Radiomic that can differentiate malignant nodules from benign nodules.

Invasive adenocarcinoma classifier

Time Frame: 30 days

Model based on Radiomic that can differentiate invasive adenocarcinoma from non-invasive adenocarcinoma.

Study Sites (1)

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