Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis and Staging of Lung Malignancies

Not Applicable

Completed

• Conditions: Mediastinal Lymphadenopathy; Lung Malignancies

• Registration Number: NCT06479798
• Lead Sponsor: Ain Shams University

Brief Summary

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging \& diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination. The present research aims to compare the diagnostic and staging accuracies of (EBUS-TBNA) versus FDG-PET /CT as two diagnostic modalities in patients with suspected lung malignancies. However as a secondary outcome this study aims at monitoring the possible complications arising post EBUS-TBNA procedure.

Detailed Description

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging \& diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination.

Objective: To compare the diagnostic and staging accuracy of convex probe EBUS-TBNA versus FDG - PET/CT as two diagnostic modalities in diagnosis of suspected lung cancer \& staging of concurrent mediastinal lymphadenopathy Patients and Methods: This prospective, interventional cohort research was performed on 40 cases with suspected lung malignancies. All cases were examined via FDG-PET/CT followed by convex probe EBUS-TBNA for diagnosis of suspected lung cancer \& staging of concurrent mediastinal lymphadenopathy.

Study Timeline

• Study Start: 2021-12-21
• Primary Completion: 2023-08-01
• Study Completion: 2023-11-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-22
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients 18 years old or more.
• Patients presented with centrally located suspiciously malignant lung masses with or without lymphadenopathy.
• patients with mediastinal lymphadenopathy only as evident by contrast - enhanced CT scan of the chest.
• patients with peripheral lung malignancy and mediastinal lymphadenopathy who were referred for MLN staging were also recruited to the research

Exclusion Criteria

• All patients who were who were unfit for bronchoscopy as per international guidelines for practice.
• Cases are diagnosed with stage IV (metastatic) lung cancer.
• Patients with histopathological diagnosis other than malignancy (as Sarcoidosis, Tuberculosis).
• patients unfit for FDG-PET G-PET/CT examination (uncontrolled Hyperglycemia, renal impairment).
• Patients who refused to participate to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT	2 years	Comparing the diagnostic yield of both modalies as they are considered primary main diagnostic and staging modalities for lung malignancies
Comparing the staging accuracies of both convex probe EBUS-TBNA versus FDG - PET/CT	2 years	Accurate staging of lung malignancies is considered crucial in determining the prognosis and specifying the treatment plan.

Secondary Outcome Measures

Name	Time	Method
Determine the complications	2 years	EBUS TBNA is a minimally invasive procedure having a very low rate of complications compared to mediastinoscopy, this study aims to monitor complications (if present)

Trial Locations

Locations (1)

Department of chest diseases , faculty of medicine; 🇪🇬 Cairo, Egypt