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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06479798
Enrollment
40
Registered
2024-06-28
Start date
2021-12-21
Completion date
2023-11-01
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Malignancies, Mediastinal Lymphadenopathy

Keywords

FDG-PET/CT, lung cancer, lung staging, EBUS-TBNA, mediastinal lymphadenopathy

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.

Interventions

DIAGNOSTIC_TESTEndo 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT2 yearsComparing 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/CT2 yearsAccurate staging of lung malignancies is considered crucial in determining the prognosis and specifying the treatment plan.

Secondary

MeasureTime frameDescription
Determine the complications2 yearsEBUS TBNA is a minimally invasive procedure having a very low rate of complications compared to mediastinoscopy, this study aims to monitor complications (if present)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026