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

Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis of Suspected Lung Cancer & Staging of Concurrent Mediastinal Lymphadenopathy at Ain-Shams University Hospitals

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.

Study Overview

• Status: Completed
• Conditions: Mediastinal Lymphadenopathy; Lung Malignancies
• Intervention / Treatment: Diagnostic test: Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Department of chest diseases , faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: FDG PET and EBUS TBNA arm; It is a single arm in which all patients undergo FDG PET and EBUS-TBNA

Diagnostic test: Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA); Endo bronchial ultrasound enables visualization of parabronchial structures throughout a bronchoscopic procedure. EBUS-TBNA, which is considered a less invasive diagnostic tool for nodal staging compared to mediastinoscopy, allows real-time, direct sampling of hilar & MLNs under sonograghic guidance with concurrent cytological and histopathological examination; Other Names: FDG-PET/CT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the complications	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)	2 years

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Emad Korraa, MD, Department of chest diseases and head of the bronchoscopy unit

Publications and helpful links

General Publications

• Sehgal IS, Agarwal R, Dhooria S, Prasad KT, Aggarwal AN. Role of EBUS TBNA in Staging of Lung Cancer: A Clinician's Perspective. J Cytol. 2019 Jan-Mar;36(1):61-64. doi: 10.4103/JOC.JOC_172_18.
• Kuo CH, Chen HC, Chung FT, Lo YL, Lee KY, Wang CW, Kuo WH, Yen TC, Kuo HP. Diagnostic value of EBUS-TBNA for lung cancer with non-enlarged lymph nodes: a study in a tuberculosis-endemic country. PLoS One. 2011 Feb 25;6(2):e16877. doi: 10.1371/journal.pone.0016877.

Helpful Links

• About EBUS TBNA

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; FDG-PET/CT; EBUS-TBNA; mediastinal lymphadenopathy; lung staging
• Additional Relevant MeSH Terms: Lymphatic Diseases; Neoplasms; Lymphadenopathy
• Other Study ID Numbers: department of chest diseases

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No