What side effects are associated with this type of intervention?

Common treatments for lung cancer include chemotherapy, radiation therapy, and surgical interventions. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and pneumonitis. Surgical interventions can result in pain, infection, and complications related to anesthesia. Specifically, for EBUS-TBNA, potential side effects include bleeding, infection, and pneumothorax (collapsed lung).

What prior FDA approvals exist?

FDA approvals for lung cancer treatments have included various targeted therapies and immunotherapies. For instance, nivolumab, an immune checkpoint inhibitor, has shown impressive responses in non-small-cell lung cancer (NSCLC) with sarcomatoid components. Additionally, the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) has been approved for advanced nonsquamous NSCLC without EGFR mutations or ALK translocations, demonstrating improved progression-free survival and overall survival. These treatments, while not directly related to EBUS-TBNA, highlight the advancements in targeted and immunotherapy approaches for lung cancer.

What other types of research exist?

Promising novel alternatives to EBUS-TBNA for lung cancer tissue sampling include transbronchial lung cryobiopsy and liquid biopsy. Transbronchial lung cryobiopsy offers higher diagnostic yield and larger tissue samples compared to traditional methods. Liquid biopsy, which analyzes circulating tumor DNA (ctDNA) in blood, provides a non-invasive option for detecting genetic mutations and monitoring treatment response.

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EBUS-TBNA Diagnostic Procedure for Early-Stage Lung Cancer

N/A

Waitlist Available

Led By George A. Eapen, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)

Patient must be > 18 years old

Must not have

Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)

Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects of EBUS-TBNA may include discomfort at the biopsy site, minor bleeding, infection risk, and rarely complications related to sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

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

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I have had chemotherapy or radiotherapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymphnode Staging Accuracy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EBUS-TBNAExperimental Treatment1 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) is a minimally invasive procedure used to obtain tissue samples from the lungs and surrounding lymph nodes. This technique is crucial for the accurate diagnosis and staging of lung cancer, particularly non-small cell lung cancer (NSCLC). The tissue samples obtained can be analyzed for molecular markers, which guide targeted therapies such as EGFR tyrosine kinase inhibitors. These targeted therapies work by blocking specific molecules involved in cancer cell growth and survival. Additionally, chemotherapy and radiation therapy are used to kill rapidly dividing cancer cells, while surgery may be employed to remove localized tumors. Understanding these mechanisms is vital for lung cancer patients as it allows for personalized treatment plans that can improve outcomes and potentially extend survival.

Efficacy and Safety of EGFR Tyrosine Kinase Inhibitors Combined with Cranial Radiotherapy for Brain Metastases from Non-Small-Cell Lung Cancer: A Protocol for a Systematic Review and Meta-Analysis.Accuracy of endoscopic ultrasound-guided needle aspiration specimens for molecular diagnosis of non-small-cell lung carcinoma.Unexpected long survival of brain oligometastatic non-small cell lung cancer (NSCLC) treated with multimodal treatment: a single-center experience and review of the literature.