Recruiting

Endobronchial Ultrasound

Sponsor:

University Health Network, Toronto

Code:

NCT01786590

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EBUS-TBNA

Study Details

Brief 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. 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.

Conditions

Lung Cancer

Study ID

NCT01786590

Start date

Feb, 2013

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT
3. Performance status score (WHO/ECOG) of 0-2.
4. Cytological or histological proof of non-small cell cancer
5. Stage T1-2 disease, with no evidence of distant metastasis
6. Patients are screened by both computed tomography (CT) and positron emission tomography (PET)
7. Medically inoperable for surgical resection
8. Patients who refused surgery

Exclusion Criteria:

1. Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
2. Active systemic, pulmonary, or pericardial infection
3. Patients who are pregnant or lactating
4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression).
5. Inability to give informed consent

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: EBUS-TBNA

Interventions

EBUS-TBNA

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.

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 ]

Central Contacts and Locations

Central contacts

Judy McConnell

judy.mcconnell@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1L7

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-04.