Lung MalignanciesNCT06479798
Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis and Staging of Lung Malignancies
A study testing Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA) in people with Lung Malignancies and Mediastinal Lymphadenopathy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Malignancies, Mediastinal Lymphadenopathy
- What is being tested?
- Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lung Malignancies, Mediastinal Lymphadenopathy
- Being tested
- Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)
- Keywords
- FDG-PET/CT, lung cancer, lung staging, EBUS-TBNA, mediastinal lymphadenopathy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)Diagnostic test
Also called FDG-PET/CT
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
| Study group | Role | What they receive |
|---|---|---|
| FDG PET and EBUS TBNA arm | Other | It is a single arm in which all patients undergo FDG PET and EBUS-TBNA Receives: Diagnostic Test: Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Determine the complications
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start21 Dec 2021
- Primary completion1 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung MalignanciesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Alzahraa, Ain Shams University
- Investigators
- Emad Korraa, MD, Study director, Department of chest diseases and head of the bronchoscopy unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479798
- Sponsor's protocol ID
- department of chest diseases
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30745743Kuo 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.
PubMed 21364919
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06479798
- Acronym / sponsor ID
- department of chest diseases
- Conditions
- Lung Malignancies, Mediastinal Lymphadenopathy
- Keywords
- FDG-PET/CT, lung cancer, lung staging, EBUS-TBNA, mediastinal lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| FDG PET and EBUS TBNA arm | Other | Diagnostic Test: Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)It is a single arm in which all patients undergo FDG PET and EBUS-TBNA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA)Also: FDG-PET/CTEndo 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 | Diagnostic test | FDG PET and EBUS TBNA arm |
Primary outcome
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
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.
1 secondary outcome
Determine the complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 30745743Sehgal 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.
- Background: PubMed 21364919Kuo 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.
- About EBUS TBNALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Korraa, MD study director
Department of chest diseases and head of the bronchoscopy unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo bronchial ultrasound transbronchial needle aspiration(EBUS-TBNA) in people with Lung Malignancies and Mediastinal Lymphadenopathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.