EBUS-TBNA Diagnostic Procedure for Early-Stage Lung Cancer

Overseen By George A. Eapen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior chemotherapy, Prior radiotherapy, Neuroendocrine histology, others

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

Compensation: Varies

Number of Visits: 7

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a procedure called EBUS-TBNA, a biopsy using ultrasound guidance, for diagnosing early-stage lung cancer. It targets patients with stage I-IIA non-small cell lung cancer who are candidates for stereotactic body radiation therapy, a form of targeted radiation. The trial will compare EBUS-TBNA results with earlier PET/CT scan findings to assess accuracy. Individuals diagnosed with or suspected of having early-stage non-small cell lung cancer and considering targeted radiation treatment may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in lung cancer diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic procedure is safe for early-stage lung cancer patients?

Research has shown that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a well-tolerated procedure. Studies have found it to be both safe and effective. This minimally invasive method collects tissue samples from the lungs to aid in diagnosis.

One study highlighted that EBUS-TBNA is very safe and highly accurate for examining chest lymph nodes for cancer signs. Most patients do not experience serious side effects. However, like any procedure, it carries risks, which are usually minor and manageable.

Overall, doctors trust EBUS-TBNA because it provides good results with minimal risk to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EBUS-TBNA diagnostic procedure because it offers a more precise way to detect early-stage lung cancer compared to current methods. Unlike traditional imaging techniques like PET/CT scans, EBUS-TBNA uses a minimally invasive approach by combining ultrasound guidance with needle aspiration, allowing doctors to take tissue samples directly from the lung's lymph nodes. This can lead to more accurate diagnosis and staging, which is crucial for planning effective treatment. Plus, the procedure has the potential to reduce unnecessary surgeries and improve patient outcomes by catching cancer earlier.

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

Research has shown that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), which participants in this trial will undergo, provides a very accurate diagnosis of lung cancer, with an accuracy rate of over 95%. This minimally invasive technique does not require large incisions and uses real-time imaging to take samples from areas near the large airways in the lungs. It is often the first choice for examining the mediastinum, the space between the lungs. EBUS-TBNA is preferred for diagnosing and determining the stage of suspected lung cancer due to its high sensitivity and specificity. ^{1 2 4 6 7}

Who Is on the Research Team?

George Eapen, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage non-small cell lung cancer (Stage I or IIa), who haven't had chemotherapy or radiotherapy for this cancer, and are being considered for a precise type of radiation therapy called SBRT. They must have had a PET/CT scan within the last 40 days and provided written consent. Cancer survivors can join if they've been free from active disease for at least five years.

Inclusion Criteria

Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures

I am being considered for a type of radiation therapy called SBRT.

My lung cancer is in the early stages (Stage I or IIa).

Exclusion Criteria

You are planning to get treatment at a different hospital or clinic.

I am already scheduled for standard cancer treatments other than at disease progression.

My cancer is a type of well-differentiated neuroendocrine tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants undergo EBUS-TBNA after PET/CT to improve lymph node staging accuracy

1 day

1 visit (in-person)

Treatment

Participants receive stereotactic body radiation therapy (SBRT)

Varies

Follow-up

Participants are monitored for survival and recurrence rates, and complications related to EBUS-TBNA and SBRT

5 years

6 weeks, then every 3 months for 2 years, twice a year for 3 years, annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)

Trial Overview The study is testing how well EBUS-TBNA works in diagnosing patients after they've had a PET/CT scan. It aims to improve accuracy in detecting early-stage lung cancer among those evaluated for stereotactic body radiation therapy.

How Is the Trial Designed?

Group I: EBUS-TBNA Experimental Treatment 1 Intervention

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed after PET/CT, and before participant receives stereotactic body radiation therapy (SBRT). EBUS-TBNA results compared with the results of PET/CT. A conventional flexible bronchoscopy performed to examine the tracheobronchial tree, followed by a systematic examination of the accessible intra-thoracic lymph nodes using a linear array ultrasound bronchoscope.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A new 25-item Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) form was developed to effectively capture the most relevant symptomatic adverse events (AEs) reported by 29 patients with non-small cell lung cancer (NSCLC) having EGFR exon 20 insertion mutations.

The study confirmed that the PRO-CTCAE items were easy for patients to understand and answer, enhancing the assessment of their experiences with AEs, which will aid in improving treatment tolerability and safety evaluations in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying symptomatic adverse events using the patient-reported outcomes version of the common terminology criteria for adverse events in patients with non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations. Zhu, Y., Jean-Baptiste, M., Lenderking, WR., et al.[2023]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

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]

In a study of 16,527 non-small cell lung cancer patients, the most common adverse events linked to pharmacotherapy were hypocalcemia, elevated creatine phosphokinase, and hypertriglyceridemia, highlighting the need for monitoring these conditions during treatment.

The modified Apriori algorithm proved to be more effective than the conventional method in identifying associations between chemotherapy drugs and adverse events, suggesting it could be a valuable tool for improving patient safety in cancer pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. Chen, W., Yang, J., Wang, HL., et al.[2022]

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]

A comprehensive analysis of 25,900 adverse event reports from 2008 to 2018 revealed that the safety profiles of drug classes for advanced melanoma treatment have diversified, with specific adverse reactions linked to different therapies.

Targeted therapies were commonly associated with skin and retinal disorders, while immunotherapies led to endocrine dysfunctions and less common issues like neuropsychiatric disorders, highlighting the need for improved management strategies by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of drugs for advanced melanoma: A report based on 2008-2018 US Food and Drug Administration Data. Casarotto, E., Noize, P., Létinier, L., et al.[2021]

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

Endobronchial ultrasound-guided transbronchial needle ... In two prospective studies, the diagnostic accuracy was determined to be >95 % [6,7]. A meta-analysis that examined the EBUS-TBNA diagnosis system for ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24484269/

Endobronchial ultrasound-guided transbronchial needle ... Needle-based techniques are now recommended as a first-line diagnostic modality for mediastinal staging. Accurate performance of systematic ...

4. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.201501-065ED

Endobronchial Ultrasound–guided Transbronchial Needle ... A large number of published studies have demonstrated high sensitivity, specificity, and diagnostic accuracy of the EBUS-TBNA in mediastinal ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncy.21431

Endobronchial ultrasound‐guided transbronchial needle ... EBUS-TBNA in patients with suspected lung cancer in many instances has become the first-line approach for cytopathologic diagnosis and staging.

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

Effectiveness and safety of endobronchial ultrasound ... Endobronchial ultrasound-guided transbronchial needle aspiration is a safe and highly accurate procedure for the examination and staging of mediastinal and ...

7. tlcr.amegroups.org tlcr.amegroups.org/article/view/80738/html

Identifying factors causing failure of nodal staging by ... The present study demonstrated the risk of false positives with ROSE and the involvement of driver oncogenes as factors associated with nodal staging failure ...