Lymph Node Sampling for Lung Cancer

Recruiting at1 trial location

Overseen by Inderdeep Dhaliwal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Pregnancy, Lactation, EBUS/EUS contraindication, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a needle guided by ultrasound to sample lymph nodes and precise high-dose radiation to treat patients with advanced lung cancer. It aims to see if sampling lymph nodes gives better information about cancer spread compared to imaging tests alone.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) and related procedures for lung cancer?

Research shows that EBUS-TFNA and related procedures are effective, minimally invasive methods for diagnosing and staging lung cancer and other mediastinal (area between the lungs) conditions. These techniques have been established as useful for both malignant and benign conditions, providing valuable diagnostic information. ^{1 2 3 4 5}

Is lymph node sampling for lung cancer using EBUS-TBNA and EUS-FNA safe?

EBUS-TBNA and EUS-FNA are generally considered safe and minimally invasive procedures for sampling lymph nodes, with low complication rates. However, rare complications like infections (mediastinitis and pericarditis) can occur. ^{4 6 7 8 9}

How does lymph node sampling for lung cancer differ from other treatments?

Lymph node sampling for lung cancer using endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is unique because it allows for real-time, minimally invasive sampling of lymph nodes, which helps in accurately staging the cancer. This method can be combined with endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) to sample more lymph nodes using a single bronchoscope, making it more efficient than traditional methods that require multiple procedures. ^{10 11 12 13 14}

Research Team

Inderdeep Dhaliwal, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Eligibility Criteria

This trial is for adults over 18 with Non-Small Cell Lung Cancer (NSCLC) who have undergone recent staging investigations. It's aimed at those with a good performance status, up to 5 metastases, and plans for radical treatment of all cancer sites. Pregnant women, individuals unable to consent, or those with contraindications to EBUS/EUS or chest radiotherapy cannot participate.

Inclusion Criteria

My lung cancer has spread to no more than 5 other places.

My cancer treatment plan was recommended by a team of cancer specialists.

I have undergone specific scans for my condition.

Exclusion Criteria

Unable to provide consent for EBUS/EUS

Pregnant or lactating women

I cannot undergo EBUS/EUS due to health reasons.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymph Node Sampling

Small pieces of suspicious chest lymph nodes are removed using EBUS-TFNA or EUS-FNA procedures

1-2 weeks

1 visit (in-person)

Radiation Treatment

Participants receive Stereotactic Ablative Radiotherapy (SABR) for treatment of small tumors

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) (Procedure)
• Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) (Procedure)

Trial Overview The study tests if sampling lymph nodes using EBUS-TFNA or EUS-FNA can better determine the extent of nodal disease in NSCLC compared to imaging alone. Participants will also receive Stereotactic Ablative Radiotherapy (SABR), a precise high-dose radiation therapy.

Participant Groups

Group I: Treatment Arm Experimental Treatment 2 Interventions

Small pieces of suspicious chest lymph nodes will be removed with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA).

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Dr. Alex Barron

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Executive Officer

Physiotherapy degree

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lisa Porter

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Roy Butler

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

MD, PhD

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

Findings from Research

In a study of 789 unique fine-needle aspiration specimens collected over 2 years, both endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) techniques demonstrated excellent diagnostic performance, particularly enhanced by the use of telepathology.

The study found a low discrepancy rate in diagnoses, with hematolymphoid neoplasms being more common in cases with discrepancies, indicating that these techniques are reliable for diagnosing malignancies and can inform improvements in training and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Comparison of Performance Parameters and Impact of Telepathology and Operator Experience on Endobronchial and Endoscopic Ultrasound-Guided Fine-Needle Aspiration. Hupp, MM., Khan, S., Dincer, HE., et al.[2021]

In a study of 19 patients suspected of having sarcoidosis, EBUS-TFNA demonstrated a high sensitivity of 84.2% and a perfect specificity of 100%, making it a reliable diagnostic tool.

When combined with transbronchial lung biopsy, EBUS-TFNA achieved a 100% diagnostic sensitivity, highlighting its effectiveness in confirming sarcoidosis while minimizing the risks associated with more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of endoscopic ultrasound-guided transbronchial fine-needle cytology in the diagnosis of sarcoidosis: A Saudi experience. Raddaoui, E., Alhamad, EH., Zaidi, SN., et al.[2020]

In a study of 30 children with mediastinal pathologies, EBUS-TBNA and EUS-B-FNA procedures demonstrated a fair diagnostic yield, confirming diagnoses in 36.6% of cases, primarily tuberculosis and one case of lymphoma.

The procedures were found to be safe, with only 3.3% of patients experiencing minor complications, indicating a strong safety profile for these techniques in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and safety of endobronchial ultrasound-guided transbronchial needle aspiration and endoscopic ultrasound with an echobronchoscope-guided fine needle aspiration in children with mediastinal pathology. Gulla, KM., Gunathilaka, G., Jat, KR., et al.[2020]

Both endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and transesophageal endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) are highly effective for diagnosing lesions, achieving diagnostic accuracy in 91% and 87% of cases, respectively.

EUS-FNA is associated with shorter procedure times, lower doses of anesthetics, and fewer oxygen desaturations compared to EBUS-TBNA, making it a potentially safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transbronchial vs transesophageal needle aspiration using an ultrasound bronchoscope for the diagnosis of mediastinal lesions: a randomized study. Oki, M., Saka, H., Ando, M., et al.[2017]

In a study involving 352 patients over two years, EBUS-guided transbronchial fine needle aspiration (TBFNA) demonstrated a high adequacy rate of 96.9% for samples, indicating its effectiveness in diagnosing and staging lung cancer and investigating mediastinal lymphadenopathy.

The use of rapid on-site evaluation (ROSE) significantly improved the process by allowing for immediate specimen triage and provisional diagnosis, with 79.5% of samples showing concordance between ROSE and final diagnoses, although a learning curve was noted for the medical staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of an endobronchial ultrasound-guided transbronchial fine needle aspiration service with rapid on-site evaluation: 2 years experience of a single UK centre. Thiryayi, SA., Rana, DN., Narine, N., et al.[2017]

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]

In a study of 132 patients who underwent EBUS-TBNA, 29.5% were aged 70 and older, and despite having more comorbidities and worse overall health, these older patients experienced no increase in complications compared to younger patients.

The diagnostic performance of EBUS-TBNA was consistent across age groups, indicating that this procedure is safe and effective for elderly patients, regardless of their health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration in elderly patients: safety and performance outcomes EBUS-TBNA in elderly. Olgun Yıldızeli, Ş., Tufan, A., Bozkurtlar, E., et al.[2022]

EBUS-TBNA is a minimally invasive and highly accurate method for staging lung cancer, showing a sensitivity of 96% and a specificity of 100% based on a study of 149 patients.

The procedure was performed safely under general anesthesia, sampling a total of 407 lymph nodes, primarily from patients diagnosed with adenocarcinoma and squamous cell carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration for lung cancer staging: early experience in Brazil. Figueiredo, VR., Cardoso, PF., Jacomelli, M., et al.[2018]

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]

A study involving 150 patients with suspected non-small cell lung cancer (NSCLC) demonstrated that combining endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) using a single bronchoscope significantly improved diagnostic accuracy, achieving a combined sensitivity of 96%.

This combined approach not only increased the sensitivity compared to each method alone but also had no reported complications, suggesting it could serve as a safer and more effective primary staging method for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer. Herth, FJ., Krasnik, M., Kahn, N., et al.[2022]

In a study involving 40 patients, both 22-gauge and 19-gauge needles used for EBUS-guided TBNA showed similar diagnostic yields for lymph node evaluation, with 87.5% and 83.9% respectively, indicating that needle size does not significantly affect diagnostic outcomes.

The study found no significant differences in sample quality or safety between the two needle sizes, and processing methods (cytologic vs. core biopsy) also did not impact the diagnostic yield or adequacy for molecular testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. Manley, CJ., Kumar, R., Gong, Y., et al.[2022]

In a study of 44 patients, the modified technique of endobronchial ultrasound-guided fine-needle capillary sampling (EBUS-FNC) successfully identified lymphadenopathies in 86.4% of cases and provided adequate samples for diagnosis in all patients, achieving a diagnostic performance of 87%.

EBUS-FNC demonstrated a sensitivity of 84% for detecting lung cancer and had a low complication rate, with only 4.5% of patients experiencing mild complications, indicating that it is a safe and effective alternative to conventional EBUS-TBNA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified technique for obtaining mediastinal samples with endobronchial ultrasound-guided transbronchial needle aspiration: results from a prospective observational study. Rodríguez, F., Seijo, LM., Sánchez, PA., et al.[2016]

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]

EBUS-TBNA is highly effective for diagnosing non-small cell lung cancer (NSCLC) in patients with enlarged hilar lymph nodes, showing a diagnostic sensitivity of 91% and specificity of 100% based on a study of 188 patients.

The procedure was safe, with no complications reported, and it provided diagnostic results comparable to those obtained from sampling central mediastinal nodes, indicating its reliability in experienced hands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of endobronchial ultrasound-guided transbronchial needle aspiration of hilar lymph nodes for diagnosing and staging cancer. Ernst, A., Eberhardt, R., Krasnik, M., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation and Comparison of Performance Parameters and Impact of Telepathology and Operator Experience on Endobronchial and Endoscopic Ultrasound-Guided Fine-Needle Aspiration. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Utility of endoscopic ultrasound-guided transbronchial fine-needle cytology in the diagnosis of sarcoidosis: A Saudi experience. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Utility and safety of endobronchial ultrasound-guided transbronchial needle aspiration and endoscopic ultrasound with an echobronchoscope-guided fine needle aspiration in children with mediastinal pathology. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Transbronchial vs transesophageal needle aspiration using an ultrasound bronchoscope for the diagnosis of mediastinal lesions: a randomized study. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Establishment of an endobronchial ultrasound-guided transbronchial fine needle aspiration service with rapid on-site evaluation: 2 years experience of a single UK centre. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration in elderly patients: safety and performance outcomes EBUS-TBNA in elderly. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration for lung cancer staging: early experience in Brazil. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. [2022]

12. Spain pubmed.ncbi.nlm.nih.gov

Modified technique for obtaining mediastinal samples with endobronchial ultrasound-guided transbronchial needle aspiration: results from a prospective observational study. [2016]

13. Japan 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. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Efficacy of endobronchial ultrasound-guided transbronchial needle aspiration of hilar lymph nodes for diagnosing and staging cancer. [2016]