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NCT Number: NCT06479798

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

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.

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Key information

Conditions

Lung Malignancies Lung Diseases Lung Neoplasms Mediastinal Lymphadenopathy Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of chest diseases , faculty of medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)

Diagnostic Test

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

Primary outcomes

  1. Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT

    Time frame: 2 years

    Comparing the diagnostic yield of both modalies as they are considered primary main diagnostic and staging modalities for lung malignancies

  2. Comparing the staging accuracies of both convex probe EBUS-TBNA versus FDG - PET/CT

    Time frame: 2 years

    Accurate staging of lung malignancies is considered crucial in determining the prognosis and specifying the treatment plan.

Secondary outcomes

  1. Determine the complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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