EBUS-TBNA for Lung Cancer

Overseen By Judy McConnell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Infections, Pregnancy, Conventional therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Varies based on individual treatment plans

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, less invasive method to stage lung cancer, crucial for planning treatment. The treatment under study, EBUS-TBNA (Endobronchial Ultrasound-guided Transbronchial Needle Aspiration), uses a special ultrasound tool to examine lymph nodes near the lungs. This method could provide precise care for people with early-stage lung cancer without surgery. The trial seeks participants with lung cancer who cannot undergo surgery and require detailed staging before radiation therapy. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future lung cancer care.

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 prior data suggests that EBUS-TBNA is safe for lung cancer patients?

Research has shown that EBUS-TBNA is a safe and well-tolerated procedure. This simple technique examines lymph nodes near the lungs. Studies indicate it is highly successful in diagnosing lung cancer.

Most patients experience very few issues. Complications are rare, occurring in only 0.04% to 17% of cases. The most common problem is infection, affecting 0.04% to 4% of patients. These low rates suggest that EBUS-TBNA is generally reliable and safe, even for older patients with other health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

EBUS-TBNA is unique because it combines endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA) to diagnose and stage lung cancer. Unlike more invasive surgical biopsies, this technique allows doctors to obtain tissue samples from lymph nodes in the chest with minimal discomfort and risk. Researchers are excited about EBUS-TBNA because it offers a less invasive, safer, and potentially quicker method for accurately diagnosing lung cancer, which could lead to faster treatment decisions and improved patient outcomes.

What evidence suggests that EBUS-TBNA is effective for lung cancer?

Research has shown that EBUS-TBNA, a technique using ultrasound to guide a needle, is promising for checking lung cancer. One study found it had a 90% accuracy rate in determining the stage of non-small-cell lung cancer, a common type. This means it can effectively show how far the cancer has spread. The procedure is minimally invasive, making it easier on the body than traditional methods. It allows doctors to check lymph nodes (small structures that help fight infection) without major surgery, which is especially helpful for older or high-risk patients. Overall, EBUS-TBNA provides a reliable and less invasive way to evaluate lung cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Kazuhiro Yasufuku, MD

Principal Investigator

UHN

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: EBUS-TBNA Experimental Treatment 1 Intervention

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

Approved in European Union as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Approved in United States as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Approved in Japan as EBUS-TBNA for:

• Mediastinal and hilar lymph node staging for non-small cell lung cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

In a study of 1,061 lymph nodes from 487 lung cancer patients, specific sonographic features such as round shape, distinct margins, heterogeneous echogenicity, and the presence of coagulation necrosis were identified as strong predictors of lymph node metastasis, with predictive accuracy ranging from 63.8% to 86.0%.

The new EBUS imaging classification system can significantly aid in determining whether lymph nodes are metastatic, as 42.9% of nodes with at least one metastatic feature were confirmed metastatic, while 96.0% of nodes without any features were confirmed non-metastatic.

NCBI (Pubmed)

pubmed.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. Fujiwara, T., Yasufuku, K., Nakajima, T., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Herth, F., Becker, HD., Ernst, A.[2022]

Endobronchial Ultrasound (EBUS) guided Transbronchial needle aspiration (TBNA) demonstrated high diagnostic accuracy for mediastinal lymphadenopathy, with a sensitivity of 98% and specificity of 100%, based on a study of 609 patients.

The use of EBUS TBNA significantly impacted patient management in 76% of cancer cases, highlighting its effectiveness in facilitating multidisciplinary cancer care without reported complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Of Mediastinal And Hilar Lymph Nodes- Five Years Of Experience At A Cancer Setting Hospital In Pakistan. Khalid, U., Akram, MJ., Butt, FM., et al.[2020]

EBUS-TBNA is a highly effective and safe method for sampling enlarged mediastinal lymph nodes in patients with non-small cell lung cancer (NSCLC), achieving a sensitivity of 95% and an accuracy of 96% based on a study of 52 patients.

The procedure was performed without complications, demonstrating its safety as a minimally invasive option for mediastinal staging in potentially operable NSCLC cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Cetinkaya, E., Seyhan, EC., Ozgul, A., et al.[2019]

In a study of 159 patients, EBUS-TBNA demonstrated a high diagnostic accuracy of 84%, effectively diagnosing both benign and malignant lung diseases, with 83% accuracy for benign conditions and 77% for malignant ones.

The use of EBUS-TBNA is particularly beneficial for diagnosing mediastinal disorders, as it significantly reduces the need for more invasive procedures like mediastinoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in various lung diseases. Ortakoylu, MG., Iliaz, S., Bahadir, A., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles of EBUS-TBNA in non-small cell lung cancer. Chung, FT., Kuo, CH., Chen, HC., et al.[2019]

A study of 24 patients who underwent EBUS-TBNA after having PCI within the last year found that the procedure is safe, with only one case of temporary atrial fibrillation and no significant cardiovascular complications.

The research indicates that EBUS-TBNA can be performed without serious adverse events in lung cancer patients post-PCI, suggesting it is a viable option for evaluating incidental lung cancer found during coronary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of endobronchial ultrasound-guided transbronchial needle aspiration in patients with lung cancer within a year after percutaneous coronary intervention. Gil, HI., Choe, J., Jeong, BH., et al.[2019]

EBUS-TBNA is generally a safe and minimally invasive procedure for diagnosing lymph node issues, but there is a risk of rare infectious complications like mediastinitis and pericarditis, even with prophylactic antibiotics.

In this case, a 67-year-old woman developed a mediastinal abscess and pericardial effusion after EBUS-TBNA, requiring intensive treatment, highlighting the need for awareness of these potential complications post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. Koh, JS., Kim, YJ., Kang, DH., et al.[2022]

A nationwide survey in Japan involving 7,345 EBUS-TBNA procedures revealed a low overall complication rate of 1.23%, with hemorrhage being the most common issue, affecting 0.68% of cases.

Despite the low complication rate, serious complications such as infections and device breakage were noted, highlighting the need for improved training and safety protocols as the use of EBUS-TBNA increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy. Asano, F., Aoe, M., Ohsaki, Y., et al.[2022]

A 67-year-old man developed acute mediastinitis 13 days after undergoing EBUS-TBNA to diagnose an enlarged mediastinal lymph node, highlighting a rare but serious complication of the procedure.

Prompt treatment with antibiotics led to significant improvement in his symptoms and laboratory markers, emphasizing the importance of monitoring for complications after EBUS-TBNA, especially in cases involving necrotic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. Kurimoto, N., Shinmyo, T., Tagay, R., et al.[2013]

Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) is a highly effective diagnostic tool for lung cancer and other pulmonary diseases, with a high diagnostic yield reported in the literature.

While complications from EBUS-TBNA are rare, this study highlights three specific cases of complications—mediastinitis, pneumothorax, and bleeding—indicating that while the procedure is generally safe, there are potential risks that should be acknowledged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. Giesa, C., Heining, L., Hecker, E., et al.[2017]

In a study of 20 patients with suspected minimal N2 disease in non-small cell lung cancer, EBUS-TBNA successfully confirmed N2 disease in 12 patients, demonstrating a sensitivity of 75% for evaluating N2 status.

The procedure was found to be safe, with no serious adverse events reported, indicating that EBUS-TBNA can be a reliable option for assessing N2 disease in potentially operable lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Feasibility Study of EBUS-TBNA for Potentially Operable Non-Small Cell Lung Cancer: The JMTO LC07-02 Study (UMIN000001280). Tanaka, F., Hasegawa, S., Kondo, N., et al.[2017]

In a study of 220 patients with non-small cell lung cancer and radiographic N0 disease, EBUS-TBNA showed a sensitivity of 36.7% and a negative predictive value (NPV) of 84.7%, indicating a significant rate of false negatives in staging lung cancer.

The false-negative rate was notably lower (5.5%) when excluding patients with occult disease outside the reach of EBUS, suggesting that EBUS-TBNA can still be valuable for staging in patients planned for nonsurgical therapies despite its limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ong, P., Grosu, H., Eapen, GA., et al.[2016]

In a study of 327 patients undergoing 337 EBUS-TBNA procedures, this minimally invasive technique demonstrated high diagnostic accuracy (89.9%) and safety, with only 0.9% experiencing minor complications.

EBUS-TBNA effectively diagnosed and staged a variety of conditions, particularly malignant diseases, and when used as a first-line investigation for non-small cell lung cancer, it significantly reduced the need for additional invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic application of endobronchial ultrasound-guided transbronchial needle aspiration: a single institution experience. Bailey, N., Krisnadi, Z., Kaur, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4367563/

Endobronchial ultrasound-guided transbronchial needle ... EBUS-TBNA is a novel, minimally invasive method to sample peribronchial masses using real-time guidance.

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0208992

Results of a French prospective multicenter trial (EVIEPEB) This two-step study evaluated the cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for presurgery staging of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125003026

Endobronchial ultrasound-guided transbronchial needle ... A meta-analysis that examined the EBUS-TBNA diagnosis system for mediastinal staging of non-small-cell lung cancer (NSCLC) reported 90 % diagnostic accuracy and ...

4. publications.ersnet.org publications.ersnet.org/content/erj/33/5/1156

Effectiveness and safety of endobronchial ultrasound ... Abstract. The aim of the present systematic review was to assess the effectiveness and safety of real time endobronchial ultrasound-guided transbronchial ...

5. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.201311-2007CI

Endobronchial Ultrasound–guided Transbronchial Needle ... Real-time endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) is an established technique for invasive mediastinal staging of non– ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9200877/

Safety and efficacy of endobronchial ultrasound‐guided ... Safety and efficacy of endobronchial ultrasound‐guided transbronchial needle aspiration (EBUS‐TBNA) for patients aged 80 years and older.

7. med.amegroups.org med.amegroups.org/article/view/10182/html

Complications of linear endobronchial ultrasound guided ... Overall complications from EBUS range from 0.04% to 17%. Most common are infectious complications which are 0.04–4%.