Lung CancerNCT01786590
Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)
A study testing EBUS-TBNA in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EBUS-TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT
- Performance status score (WHO/ECOG) of 0-2.
- Cytological or histological proof of non-small cell cancer
- Stage T1-2 disease, with no evidence of distant metastasis
- Patients are screened by both computed tomography (CT) and positron emission tomography (PET)
- Medically inoperable for surgical resection
- Patients who refused surgery
Who cannot join
- Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
- Active systemic, pulmonary, or pericardial infection
- Patients who are pregnant or lactating
- Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression).
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Judy McConnell contact
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 1L7
Judy McConnell, BSc.Hon, CCRP, 416-581-7486, judy.mcconnell@uhn.ca
Alexandria Grindlay, 416-581-7066, alexandria.grindlay@uhn.ca
About this study
It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.
Read the detailed description
Patients with radiologically early stage lung cancer who are candidates for SBRT will be enrolled in this study. Prior to enrollment, patients are required to be evaluated by an experienced thoracic surgeon, radiation oncologist or medical oncologist to determine operability. Patients will udergo computed tomography (CT) and positron emission tomography (PET) prior to EBUS- TBNA. EBUS-TBNA will be performed at the Interventional Thoracic Surgery Suite (ITSS) located at Toronto General Hospital by a Thoracic Surgeon. The procedure will be performed under local anesthesia with conscious sedation. Mediastinal as well as hilar lymph nodes will be assessed by EBUS-TBNA. The result of pathological diagnosis using EBUS-TBNA will be compared with the result of radiological staging (CT and PET-CT). Patients who are negative for mediastinal lymph node metastasis by EBUS-TBNA will undergo SBRT. In addition, the treatment outcome will be evaluated based on the clinical chart review.
- Conditions
- Lung Cancer
- Being tested
- EBUS-TBNA
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNAProcedure or surgery
Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Experimental | Not described Receives: Procedure: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).
Primary objective: To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).
In comparing EBUS-TBNA vs. CT/PET the primary outcome measures will be:
- Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy
Measured: 3 years
Secondary outcomes (1)
The treatment outcome (nodal recurrence rate) will be evaluated based on clinical chart review.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Yasufuku, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786590
- Sponsor's protocol ID
- 12-5294-CE
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2013
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)
- ClinicalTrials.gov ID
- NCT01786590
- Acronym / sponsor ID
- 12-5294-CE
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Feb 2013 (estimated)
- 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.
It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.
Detailed description
Patients with radiologically early stage lung cancer who are candidates for SBRT will be enrolled in this study. Prior to enrollment, patients are required to be evaluated by an experienced thoracic surgeon, radiation oncologist or medical oncologist to determine operability. Patients will udergo computed tomography (CT) and positron emission tomography (PET) prior to EBUS- TBNA. EBUS-TBNA will be performed at the Interventional Thoracic Surgery Suite (ITSS) located at Toronto General Hospital by a Thoracic Surgeon. The procedure will be performed under local anesthesia with conscious sedation. Mediastinal as well as hilar lymph nodes will be assessed by EBUS-TBNA. The result of pathological diagnosis using EBUS-TBNA will be compared with the result of radiological staging (CT and PET-CT). Patients who are negative for mediastinal lymph node metastasis by EBUS-TBNA will undergo SBRT. In addition, the treatment outcome will be evaluated based on the clinical chart review.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Experimental | Procedure: EBUS-TBNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT
- Performance status score (WHO/ECOG) of 0-2.
- Cytological or histological proof of non-small cell cancer
- Stage T1-2 disease, with no evidence of distant metastasis
Key exclusion criteria (5 listed)
- Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
- Active systemic, pulmonary, or pericardial infection
- Patients who are pregnant or lactating
- Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression).
- Inability to give informed consent
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 |
|---|---|---|
| EBUS-TBNACurrently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT. | Procedure or surgery | EBUS-TBNA |
Primary outcome
To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).
Time frame: 3 years
Primary objective: To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT). In comparing EBUS-TBNA vs. CT/PET the primary outcome measures will be: 1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy
1 secondary outcome
The treatment outcome (nodal recurrence rate) will be evaluated based on clinical chart review.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
Judy McConnell contact
Kazuhiro Yasufuku, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBNA in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy McConnell (judy.mcconnell@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT). (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.