Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)

NCT01786590 | Recruiting

• 1 other identifier: 12-5294-CE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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: 1\) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy

  3 years

Secondary Outcomes (1)

• The treatment outcome (nodal recurrence rate) will be evaluated based on clinical chart review.

  5 years

Study Arms (1)

EBUS-TBNA

EXPERIMENTAL

Procedure: EBUS-TBNA

Interventions

EBUS-TBNA PROCEDURE

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.

EBUS-TBNA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kazuhiro Yasufuku, MD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy McConnell

CONTACT

judy.mcconnell@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (1)