Clinical trial NCT06479798: Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis and Staging of Lung Malignancies
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Malignancies
Mediastinal Lymphadenopathy
Keywords: FDG-PET/CT
lung cancer
lung staging
EBUS-TBNA
mediastinal lymphadenopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT
timeFrame: 2 years
measure: Comparing the staging accuracies of both convex probe EBUS-TBNA versus FDG - PET/CT
timeFrame: 2 years
Secondary outcomes:
measure: Determine the complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of chest diseases , faculty of medicine
Study officials:
affiliation: Department of chest diseases and head of the bronchoscopy unit
name: Emad Korraa, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.