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OpenTrials
Completed

NCT Number: NCT06351319

Ultrasound Imaging Based on Ultrasound Bronchoscopy in Respiratory Diseases: a Retrospective, Single-center, Confirmatory Study

ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.

Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory and Critical Care Medicine

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1)chest CT showing enlarged mediastinal or hilar lymph nodes or positive findings of mediastinal and hilar lymph nodes on PET/CT (SUV≥2.5); (2)patients who underwent EBUS-TBNA examination; (3)no contraindications for surgery.

Exclusion criteria

  • (1)prior treatment of target lymph nodes before EBUS-TBNA; (2)unclear diagnostic results; (3)loss to follow-up.

Treatment and study plan

SVM model

Diagnostic Test

Bronchoscopic ultrasound images were analyzed according to SVM mode

Primary outcomes

  1. AUC

    Time frame: One month

    Judge the validity and accuracy of the model

  2. accuracy

    Time frame: One month

    Judge the validity and accuracy of the model

  3. sensitivity

    Time frame: One month

    Judge the validity and accuracy of the model

  4. specificity

    Time frame: One month

    Judge the validity and accuracy of the model

Sponsors and collaborators

Lead sponsor

Quncheng Zhang

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
May 24, 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.