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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well using ultrasound and a needle to take lung tissue samples after an imaging scan works in diagnosing early-stage lung cancer. It aims to improve the accuracy of determining the cancer stage in patients being considered for a specific type of radiation therapy.

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 data supports the effectiveness of the treatment Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for early-stage lung cancer?

EBUS-TBNA is highly effective for diagnosing and staging lung cancer, as it allows doctors to sample tissue from lung masses and lymph nodes near the airways. It is widely accepted as the first procedure for lung cancer staging and has a high diagnostic yield, meaning it is very successful in providing accurate results. ^{1 2 3 4 5}

Is the EBUS-TBNA procedure generally safe for humans?

The provided research articles do not contain specific safety data for the EBUS-TBNA procedure, but this procedure is generally considered safe with a low risk of complications, such as minor bleeding or infection, based on existing medical literature. ^{6 7 8 9 10}

How is the EBUS-TBNA treatment different from other treatments for early-stage lung cancer?

EBUS-TBNA is unique because it is a minimally invasive procedure that uses ultrasound to guide a needle to sample tissue from the lungs or surrounding lymph nodes, helping diagnose and stage lung cancer without the need for more invasive surgery. This makes it particularly useful for early-stage lung cancer where other accessible tissue samples are not available. ^{5 11 12 13 14}

Research Team

George Eapen, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[The Diagnostic Value of Endobronchial Ultrasound-guided Needle Aspiration Biopsy for Lung or Mediastinal Lymph Node Cancer and Tuberculosis]. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[Value of endobronchial ultrasound-guided transbronchial needle aspiration in hilar and mediastinal lesions]. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration in routine care - plenty of benign results and follow-up tests. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Impact of simulation training on performance and outcomes of endobronchial ultrasound-guided transbronchial needle aspiration performed by trainees in a tertiary academic hospital. [2022]

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

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Diagnosis and Staging of Lung Cancer. [2019]

6. United States 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. [2023]

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

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. [2022]

8. Switzerland 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. [2023]

9. China pubmed.ncbi.nlm.nih.gov

[Efficacy of erlotinib on advanced non-small cell lung cancer]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Safety profile of drugs for advanced melanoma: A report based on 2008-2018 US Food and Drug Administration Data. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A pragmatic application of endobronchial ultrasound-guided transbronchial needle aspiration: a single institution experience. [2020]

12. Brazil pubmed.ncbi.nlm.nih.gov

Diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration in various lung diseases. [2018]

13. Brazil pubmed.ncbi.nlm.nih.gov

Diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration for mediastinal staging in lung cancer. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Values of different specimen preparation methods for the diagnosis of lung cancer by endobronchial ultrasound guided transbronchial needle aspiration. [2021]