Clinical trial NCT04328792: Prediction Model of CP-EBUS in the Diagnosis of Lymph Nodes
Official title: Prediction Model Based on Deep Learning of CP-EBUS Multimodal Image in the Diagnosis of Benign and Malignant Lymph Nodes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymph Node Disease
Keywords: EBUS-TBNA
Intrathoracic lymph node
Multimodal image
Deep learning
Prediction model
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with enlarged intrathoracic LNs that need to be diagnosed by EBUS-TBNA are enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic efficacy of EBUS multimodal artificial intelligence prediction model based on videos
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Diagnostic efficacy of traditional qualitative and quantitative methods
timeFrame: 6 months post-procedure
measure: Diagnostic efficacy of multimodal deep learning model based on images
timeFrame: 6 months post-procedure
measure: Comparion of prediction model based on deeping learning with traditional qualitative and quantitative methods
timeFrame: 6 months post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
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