150 Participants Needed

EBUS-TBNA for Lung Cancer

JM
Overseen ByJudy McConnell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are planning to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery, you may not be eligible for this trial.

What data supports the effectiveness of the treatment EBUS-TBNA for lung cancer?

EBUS-TBNA is a minimally invasive procedure that helps in diagnosing and staging lung cancer by improving the accuracy of identifying cancer spread to lymph nodes. It is particularly useful for non-small cell lung cancer and has shown potential in increasing the diagnostic yield compared to conventional methods.12345

Is EBUS-TBNA safe for humans?

EBUS-TBNA is generally considered safe, but there are rare reports of complications like infections, bleeding, and air leaks in the chest. Most studies show that these issues are uncommon, especially when performed by experienced doctors.678910

How is the treatment EBUS-TBNA unique for lung cancer?

EBUS-TBNA is a unique, minimally invasive procedure that uses ultrasound to guide a needle through the airways to sample lymph nodes in the chest, helping to diagnose and stage lung cancer without the need for more invasive surgery.1112131415

Research Team

KY

Kazuhiro Yasufuku, MD

Principal Investigator

UHN

Eligibility Criteria

This trial is for adults over 18 with confirmed non-small cell lung cancer who can't have surgery or chose not to. They should be in fair health (performance status 0-2), have early-stage T1-2 disease without distant metastasis, and need EBUS-TBNA staging before SBRT treatment. Pregnant women, those unfit for bronchoscopy, or planning other treatments are excluded.

Inclusion Criteria

I need a specific lung biopsy before starting a targeted radiation treatment.
I can take care of myself and am up and about more than 50% of my waking hours.
Patients need to have both CT and PET scans before joining the study.
See 4 more

Exclusion Criteria

You are not healthy enough to undergo a bronchoscopy procedure based on your overall medical condition.
I currently have an infection in my body, lungs, or around my heart.
I am unable to understand and agree to the study's details.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Evaluation

Patients undergo CT and PET scans prior to EBUS-TBNA to determine operability and assess lymph nodes

1-2 weeks
1 visit (in-person)

EBUS-TBNA Procedure

Endobronchial ultrasound-guided transbronchial needle aspiration is performed to assess mediastinal and hilar lymph nodes

1 day
1 visit (in-person)

Treatment

Patients negative for mediastinal lymph node metastasis undergo stereotactic body radiotherapy (SBRT)

Varies based on individual treatment plans

Follow-up

Participants are monitored for treatment outcomes and safety through clinical chart reviews

3 years

Treatment Details

Interventions

  • EBUS-TBNA
Trial Overview The trial tests the use of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for lymph node staging in patients with lung cancer who will undergo Stereotactic Body Radiotherapy (SBRT). It aims to provide a less invasive option for accurate diagnosis and treatment planning.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EBUS-TBNAExperimental Treatment1 Intervention

EBUS-TBNA is already approved in European Union, United States, Japan for the following indications:

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Approved in European Union as EBUS-TBNA for:
  • Mediastinal and hilar lymph node staging for non-small cell lung cancer
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Approved in United States as EBUS-TBNA for:
  • Mediastinal and hilar lymph node staging for non-small cell lung cancer
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Approved in Japan as EBUS-TBNA for:
  • Mediastinal and hilar lymph node staging for non-small cell lung cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

In a randomized trial involving 200 patients, endobronchial ultrasound (EBUS) guidance significantly improved the yield of transbronchial needle aspiration (TBNA) in most lymph node stations, with yields of 84% for EBUS compared to 58% for conventional TBNA in group B (p < 0.001).
However, in the subcarinal region (group A), the difference in yield between EBUS and conventional TBNA was not significant (86% vs 74%), suggesting that EBUS may not provide additional benefits in this specific area.
Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial.Herth, F., Becker, HD., Ernst, A.[2022]
Endobronchial ultrasound-guided transbronchial aspiration (EBUS-TBNA) demonstrated high diagnostic accuracy in non-small cell lung cancer (NSCLC) patients, with an overall sensitivity of 92.3% and specificity of 100% across 164 patients studied from 2007 to 2009.
The use of EBUS-TBNA not only effectively diagnosed and staged NSCLC but also allowed 54.7% of patients with confirmed malignancy to avoid unnecessary surgery, highlighting its role as a less invasive initial diagnostic tool.
Roles of EBUS-TBNA in non-small cell lung cancer.Chung, FT., Kuo, CH., Chen, HC., et al.[2019]
In a study involving 102 patients with suspected lung cancer metastasis, both 22-gauge (G) and 25G needles showed similar diagnostic yields for detecting malignancy (75% each), indicating that either needle can be effectively used for EBUS-TBNA.
However, the 22G needle provided significantly larger tissue samples and a higher number of malignant cells compared to the 25G needle, suggesting it is the preferred choice for better specimen quality.
Comparison of the efficiency of endobronchial ultrasound-guided transbronchial needle aspiration using a 22G needle versus 25G needle for the diagnosis of lymph node metastasis in patients with lung cancer: a prospective randomized, crossover study.Sakai, T., Udagawa, H., Kirita, K., et al.[2022]

References

Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. [2022]
Roles of EBUS-TBNA in non-small cell lung cancer. [2019]
Comparison of the efficiency of endobronchial ultrasound-guided transbronchial needle aspiration using a 22G needle versus 25G needle for the diagnosis of lymph node metastasis in patients with lung cancer: a prospective randomized, crossover study. [2022]
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Of Mediastinal And Hilar Lymph Nodes- Five Years Of Experience At A Cancer Setting Hospital In Pakistan. [2020]
Endobronchial ultrasound-guided transbronchial needle aspiration for systematic nodal staging of lung cancer in patients with N0 disease by computed tomography and integrated positron emission tomography-computed tomography. [2016]
Safety of endobronchial ultrasound-guided transbronchial needle aspiration in patients with lung cancer within a year after percutaneous coronary intervention. [2019]
Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]
Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy. [2022]
[A case of acute mediastinitis after endobronchial needle aspiration]. [2013]
Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. [2017]
A pragmatic application of endobronchial ultrasound-guided transbronchial needle aspiration: a single institution experience. [2020]
A Multicenter Feasibility Study of EBUS-TBNA for Potentially Operable Non-Small Cell Lung Cancer: The JMTO LC07-02 Study (UMIN000001280). [2017]
Efficacy of convex probe endobronchial ultrasound (CP-EBUS) assisted transbronchial needle aspiration for mediastinal staging in non-small cell lung cancer cases with mediastinal lymphadenopathy. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
The utility of sonographic features during endobronchial ultrasound-guided transbronchial needle aspiration for lymph node staging in patients with lung cancer: a standard endobronchial ultrasound image classification system. [2022]
Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in various lung diseases. [2018]