Lymph Node Sampling for Lung Cancer

Recruiting at 1 trial location

Overseen By David Palma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: 1

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sampling suspicious chest lymph nodes can better determine the extent of disease in people with metastatic non-small cell lung cancer (NSCLC) compared to relying solely on imaging tests. The procedure, endobronchial ultrasound-guided fine needle aspiration (EBUS-TFNA), collects small tissue samples from lymph nodes. The study also involves Stereotactic Ablative Radiotherapy (SABR), a precise radiation treatment known for its high-dose accuracy on small tumors. People with NSCLC who have up to five metastases and plan to receive radical treatment might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future diagnostic and treatment strategies.

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 prior data suggests that these procedures are safe for lymph node sampling?

Research has shown that both EBUS-TFNA and EUS-FNA are safe and well-tolerated methods for sampling lymph nodes in the chest. EBUS-TFNA, a less invasive procedure, allows doctors to collect tissue samples with real-time guidance, aiding in accurate diagnosis and staging of lung cancer. Many studies have demonstrated its effectiveness and safety, with a high rate of accurate diagnosis.

Similarly, EUS-FNA is a safe and reliable method for obtaining tissue samples. Research indicates that it is well-tolerated by patients and effective in diagnosing lung cancer and other chest conditions. These procedures enable doctors to assess cancer spread without major surgery, reducing patient risks. Overall, both methods have strong safety records in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques, EBUS-TFNA and EUS-FNA, because they offer a minimally invasive way to sample lymph nodes in the chest for lung cancer diagnosis. Unlike traditional surgical biopsies, these methods use ultrasound guidance to precisely target and collect tissue samples through the airways or esophagus, reducing the need for more invasive procedures. This approach not only minimizes patient discomfort and recovery time but also provides a quicker path to diagnosis, which is crucial for timely cancer treatment.

What evidence suggests that these lymph node sampling procedures are effective for determining the extent of nodal disease in metastatic NSCLC?

This trial will compare two procedures for lymph node sampling in lung cancer: endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) and transesophageal ultrasound-guided fine needle aspiration (EUS-FNA). Research has shown that EBUS is highly effective for diagnosing lung cancer, with studies reporting a 90% accuracy rate in determining the stage of non-small cell lung cancer (NSCLC). EUS is also effective, diagnosing lung cancer in about half of the cases studied. Both procedures are safe and less invasive than traditional surgeries. They help doctors assess the extent of cancer spread, which is crucial for planning treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Inderdeep Dhaliwal, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Are You a Good Fit for This Trial?

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

Pregnant or lactating women

Unable to provide consent for EBUS/EUS

I cannot undergo EBUS/EUS due to health reasons.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

Published Research Related to This Trial

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 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 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 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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

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

Endobronchial ultrasound-guided transbronchial needle ... Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) offers a minimally invasive alternative to mediastinoscopy with additional ...

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24760496/

Endobronchial ultrasound-guided transbronchial needle ... EBUS-TBNA has emerged as a minimally invasive technique for evaluating the mediastinum and staging patients with lung cancer.

4. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-022-02266-7

Endobronchial ultrasound-guided transbronchial needle ... This study aimed to evaluate the use of EBUS-TBNA in patients with suspicious LNs after anti-tumor therapy for lung cancer or other malignancies ...

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

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

6. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1383600/full

Endobronchial ultrasound-guided transbronchial needle ... EBUS-TBNA is a minimally invasive technique for biopsy of lung, peri-pulmonary tissue and lymph nodes under real-time ultrasound-guided biopsy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123000197

Endobronchial ultrasound bronchoscopy Franseen fine ... The FNB needle demonstrated higher diagnostic yield in benign lymphadenopathy and higher quality for NGS than standard FNA needle.