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

NCT06479798 | Completed

• 1 other identifier: department of chest diseases
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Malignancies; Mediastinal Lymphadenopathy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Determine the complications

  2 years

Study Arms (1)

FDG PET and EBUS TBNA arm

OTHER

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)

Interventions

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

Also known as: FDG-PET/CT

FDG PET and EBUS TBNA arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Department of chest diseases , faculty of medicine

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 30745743 BACKGROUND

• 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.

  PMID: 21364919 BACKGROUND

Related Links

• About EBUS TBNA

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emad Korraa, MD

  Department of chest diseases and head of the bronchoscopy unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of pulmonology

Model Details: 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 Record Dates

• First Submitted: June 22, 2024
• First Posted: June 28, 2024
• Study Start: December 21, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)