Radiomics Multifactorial Biomarker for Pulmonary Nodules

NCT ID: NCT03872362

Last Updated: 2019-03-13

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

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-11

Study Completion Date

2019-02-01

Brief Summary

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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

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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.

Conditions

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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lung Diseases Neoplasms Pathology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Training dataset

No interventions

radiomics

Intervention Type DIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

External validation1

No interventions

radiomics

Intervention Type DIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

External validation2

No interventions

radiomics

Intervention Type DIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

Interventions

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radiomics

The high-throughput extraction of large amounts of quantitative image features from medical images

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Zhongshan Hospital of Dalian University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Fifth Hospital of Dalian

UNKNOWN

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Site Status

Countries

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China

References

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Wu G, Woodruff HC, Shen J, Refaee T, Sanduleanu S, Ibrahim A, Leijenaar RTH, Wang R, Xiong J, Bian J, Wu J, Lambin P. Diagnosis of Invasive Lung Adenocarcinoma Based on Chest CT Radiomic Features of Part-Solid Pulmonary Nodules: A Multicenter Study. Radiology. 2020 Nov;297(2):451-458. doi: 10.1148/radiol.2020192431. Epub 2020 Aug 25.

Reference Type DERIVED
PMID: 32840472 (View on PubMed)

Other Identifiers

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UM2019DLABGY1

Identifier Type: -

Identifier Source: org_study_id

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