Prediction Model of Peripheral Pulmonary Lesions Based on R-EBUS Image

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Peripheral pulmonary lesions(PPLs) have a wide spectrum of diseases, and the diagnosis will affect the treatment strategy and prognosis. Radial endobronchial ultrasound (R-EBUS) can be used for non-invasive diagnosis of PPLs, and the supplement pathological diagnosis results of EBUS-TBLB, which has important clinical application value. This project intends to select representative images from R-EBUS dynamic videos for qualitative and quantitative analysis, to establish and verify the diagnostic evaluation system of R-EBUS forPPLs. Then build 1,000 R-EBUS image databases of PPLs, train deep learning networks for automatic extraction and diagnosis of target areas, and automatically extract representative images from videos to establish a benign and malignant prediction model of PPLs. We will provide reliable theoretical basis for the diagnosis of PPLs, and optimize the diagnosis and treatment method.The network would be prospectively verified through 300 R-EBUS images from multi centers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

NCT01895166

Lung Cancer

UNKNOWN NA

EBUS Image Features in the Diagnosis of PPLs

NCT03575715

Endobronchial Ultrasound

UNKNOWN NA

Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

NCT05512533

Peripheral Pulmonary Lesions

COMPLETED NA

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

NCT04328792

Lymph Node Disease

UNKNOWN

A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes

NCT07060378

Lung Lesions Mediastinal and Hilar Lymph Node Enlargement

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PPLs are lesions at tertiary bronchus and above. The lesion cannot be seen by conventional bronchoscopy and the diagnosis will affect the treatment strategy and prognosis. R-EBUS can be used for non-invasive diagnosis of PPLs, and the supplement pathological diagnosis results of EBUS-TBLB. During the procedure, target PPLs are examined by ultrasound host (EU-ME2, Olympus, Tokyo, Japan) equipped with Doppler function and ultrasound probe . The bronchoscope reaches the distal as far as possible according to the predetermined position on chest CT or positron emission tomography-computed tomography (PET-CT) . The R-EBUS probe is inserted into the working channel of the bronchoscope, and gradually approaches the target PPL to obtain R-EBUS image. According to the characteristics such as within or adjacent to image, the probe scan the lesion from the near end to the far end and record the video. The recording time is required longer than 10 seconds. After selecting a typical R-EBUS image, freeze the image and take a screenshot. The long and short diameter of the lesion will be measured. This project includes three parts: preliminary construction and evaluation of R-EBUS image system for benign and malignant PPLs, construction of R-EBUS artificial intelligence prediction model and multi-center prospective validation of the prediction model. A total of 1000 patients will be enrolled to construct diagnostic model and 300 are enrolled to verify the diagnostic effiency.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnoses Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prospectively validation group

Two diagnosis methods will be used in the prospective validation section, one is traditional qualitative and quantitative method, the other is artificial intelligence prediction model based on videos to compare the diagnostic efficacy.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with PPLs in Chest CT or PET / CT;
2. Chest CT or PET / CT shows PPLs with diameter greater than 8 mm;
3. Patients agree to perform EBUS-TBLB and sign the informed consent.

Exclusion Criteria

1. Thin-layer Chest CT or PET / CT indicates lack of bronchial access to PPLs;
2. Patients refuse to participate in this clinical trial;
3. Patients with severe cardiopulmonary dysfunction or other indications that not allowed for bronchoscopy;
4. Visible lesions in the lumen during conventional bronchoscopy;
5. Patients have other related contraindications of bronchoscopy;
6. Patients have other reasons unfit for this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No