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

NCT ID: NCT06479798

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Lung Malignancies Mediastinal Lymphadenopathy

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FDG PET and EBUS TBNA arm

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

Group Type OTHER

Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FDG-PET/CT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Alzahraa

Assistant lecturer of pulmonology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad Korraa, MD

Role: STUDY_DIRECTOR

Department of chest diseases and head of the bronchoscopy unit

Locations

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Department of chest diseases , faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 30745743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21364919 (View on PubMed)

Related Links

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Other Identifiers

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department of chest diseases

Identifier Type: -

Identifier Source: org_study_id