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Prediction Model of CP-EBUS in the Diagnosis of Lymph Nodes

Prediction Model Based on Deep Learning of CP-EBUS Multimodal Image in the Diagnosis of Benign and Malignant Lymph Nodes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04328792
Enrollment
1300
Registered
2020-03-31
Start date
2018-07-01
Completion date
2020-12-31
Last updated
2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Disease

Keywords

EBUS-TBNA, Intrathoracic lymph node, Multimodal image, Deep learning, Prediction model

Brief summary

Endobronchial ultrasound (EBUS) multimodal image including grey scale, blood flow doppler and elastography, can be used as non-invasive diagnosis and supplement the pathological result, which has important clinical application value. In this study, EBUS multimodal image database of 1000 inthoracic benign and malignant lymph nodes (LNs) will be constructed to train deep learning neural networks, which can automatically select representative images and diagnose LNs. Investigators will establish an artificial intelligence prediction model based on deep learning of intrathoracic LNs, and verify the model in other 300 LNs.

Detailed description

Intrathoracic LNs enlargement has a wide range of diseases, among which intrathoracic LNs metastasis of lung cancer is the most common malignant disease. Benign lesions, including inflammation, tuberculosis and sarcoidosis, also need to be differentiated for targeted treatment. EBUS multimodal image including grey scale, blood flow doppler and elastography, can be used as non-invasive diagnosis and supplement the pathological result, which has important clinical application value. This study includes two parts: retrospectively construction of EBUS artificial intelligence prediction model and multi-center prospectively validation of the prediction model. A total of 1300 LNs will be enrolled in the study. During the retention of videos, target LNs and peripheral vessels are examined using ultrasound hosts (EU-ME2, Olympus or Hi-vision Avius, Hitachi) equipped with elastography and doppler functions and ultrasound bronchoscopy (BF-UC260FW, Olympus or EB1970UK, Pentax). Multimodal image data of target LNs are collected. Investigators will construct artificial intelligence prediction model based on deep learning using images from 1000 LNs firstly, and verify the model in other 300 LNs. This model will be compared with traditional qualitative and quantitative evaluation methods to verify the diagnostic efficacy.

Interventions

None listed

Sponsors

Shanghai Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Chest CT shows enlarged intrathoracic LNs (short diameter \> 1 cm) or PET / CT shows patients with increased FDG uptake (SUV ≧ 2.0) in intrathoracic LNs; 2. Operating physician considered EBUS-TBNA should be performed on LNs for diagnosis or preoperative staging of lung cancer; 3. Patients agree to undergo EBUS-TBNA, sign informed consent, and have no contraindications.

Exclusion criteria

\- Patients having other situations that are not suitable for EBUS-TBNA.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic efficacy of EBUS multimodal artificial intelligence prediction model based on videos6 months post-procedureDiagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy.

Secondary

MeasureTime frameDescription
Diagnostic efficacy of traditional qualitative and quantitative methods6 months post-procedureDiagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy.
Diagnostic efficacy of multimodal deep learning model based on images6 months post-procedureDiagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy.
Comparion of prediction model based on deeping learning with traditional qualitative and quantitative methods6 months post-procedureDiagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy.

Countries

China

Contacts

Primary ContactJiayuan Sun, MD, PhD
jysun1976@163.com86-21-22200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026