Endobronchial Ultrasound for Lung Cancer

(OPTIMAL Trial)

Overseen By Marc Fortin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Disqualifiers: Other modality preferred by physician

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for collecting lung tissue samples using endobronchial ultrasound, a procedure that allows doctors to see inside the lungs, to diagnose and treat suspected non-small cell lung cancer (NSCLC). The trial compares two methods: taking tissue samples from the lung with either two or three passes of the ultrasound tool to determine which provides better results for genetic testing. The goal is to identify which method yields enough material for next-generation sequencing, a detailed DNA test, and to assess how well liquid biopsy, a blood test, can detect important cancer information. Suitable participants have suspected NSCLC and require a tissue sample for DNA testing, with at least two suspicious lung areas accessible by ultrasound. As an unphased trial, this study offers a unique opportunity to contribute to innovative diagnostic methods that could enhance future lung cancer care.

What prior data suggests that endobronchial ultrasound is safe for lung cancer patients?

Research has shown that endobronchial ultrasound (EBUS) is generally safe for patients. One study involving 30,570 patients found EBUS to be a well-tolerated procedure, preferred over more invasive methods, underscoring its safety and effectiveness.

Another review confirmed EBUS as a safe and cost-effective technique, meaning it works well and rarely causes side effects. Many doctors find it useful for diagnosing lung issues.

Overall, evidence suggests that EBUS is a safe option for evaluating lung conditions. It has been widely used and has a strong track record of not causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endobronchial ultrasound (EBUS) is unique because it offers a minimally invasive way to evaluate and diagnose lung cancer, potentially improving accuracy and patient comfort compared to more invasive surgical biopsies or traditional imaging methods. Researchers are excited about this trial because it explores the effectiveness of performing multiple passes (either two or three) per target during EBUS, which may enhance diagnostic yield and precision. By refining this method, the trial could lead to better diagnostic practices and outcomes for lung cancer patients, potentially catching the disease earlier and more accurately.

What evidence suggests that endobronchial ultrasound is effective for lung cancer?

Research has shown that endobronchial ultrasound (EBUS) reliably diagnoses non-small cell lung cancer (NSCLC). Studies have found that EBUS accurately identifies lung cancer in many patients. It is also considered a safe and affordable procedure compared to more invasive surgeries. Additionally, EBUS aids doctors in collecting tissue samples needed for detailed genetic testing, which can help create personalized treatment plans. This trial will compare two different approaches to EBUS: one arm will involve 2 passes per target, while the other will involve 3 passes per target. Overall, EBUS is a proven tool in the fight against lung cancer, assisting doctors in diagnosing and planning treatments effectively. ^{2 5 6 7 8}

Who Is on the Research Team?

Marc Fortin

Principal Investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Are You a Good Fit for This Trial?

This trial is for individuals suspected or confirmed to have non-small cell lung cancer (NSCLC) who need a tissue sample for genetic testing to guide their treatment. They must have at least two targets accessible by endobronchial ultrasound that are suspicious of malignancy.

Inclusion Criteria

My lung cancer needs a biopsy for genetic testing.

I have at least 2 areas suspicious for cancer that can be reached for biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Endobronchial Ultrasound and Biopsy

Participants undergo endobronchial ultrasound and are randomized to 2 vs 3 passes per lymph node, with all undergoing liquid biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for the adequacy of material for NGS testing and additional clinical findings from liquid biopsy

1 month

1 visit (virtual)

Long-term Follow-up

Review of cell blocks by a blinded pathologist to assess adequacy rate for NGS testing

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial ultrasound

Trial Overview

The study tests whether taking fewer samples during an endobronchial ultrasound can still provide enough material for next-generation sequencing, which is important for NSCLC treatment decisions. It also examines if liquid biopsies can reveal critical information not found in tissue biopsies.

How Is the Trial Designed?

Group I: 3 passes per target on EBUS Experimental Treatment 1 Intervention

Group II: 2 passes per target on EBUS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials

26

Recruited

6,300+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38466540/

effectiveness and accuracy in non-small cell lung cancer ...

EBUS-TBNA is a safe and effective procedure that offers high sensitivity and specificity when performed together with ROSE, which improves the accuracy of ...

2.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(23)03789-3/fulltext

A REVIEW OF DATA AND OUTCOMES OF AN ...

The goal of this study is to review clinical data from the standpoint of community pulmonologists who received training in use of Endobronchial ultrasound- ...

3.

archbronconeumol.org

archbronconeumol.org/en-ten-years-linear-endobronchial-ultrasound-articulo-S1579212915004413

Ten Years of Linear Endobronchial Ultrasound: Evidence ...

The analysis shows that EBUS-TBNA is a safe, cost-effective technique with a high grade of evidence that is a valuable tool in the diagnosis and mediastinal ...

4.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK97265/

Clinical effectiveness and cost-effectiveness of endobronchial ...

Clinical effectiveness and cost-effectiveness of endobronchial and endoscopic ultrasound relative to surgical staging in potentially resectable lung cancer: ...

5.

southcarolinablues.com

southcarolinablues.com/web/public/brands/medicalpolicyih/external-policies/endobronchial-ultrasound-for-diagnosis-and-staging-of-lung-cancer/

InStil Health Medical Policies

Endobronchial ultrasound guidance with transbronchial needle biopsy may be considered MEDICALLY NECESSARY for the evaluation of peripheral pulmonary lesions in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7609959/

Safety and Costs of Endobronchial Ultrasound-Guided Nodal ...

We compared the risks and costs of endobronchial ultrasound (EBUS)-guided nodal aspiration and mediastinoscopy performed for any indication in a large national ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369219340024

Safety and Costs of Endobronchial Ultrasound-Guided ...

Results. Among 30,570 patients undergoing mediastinal nodal evaluation, 49% underwent EBUS. The frequency of EBUS increased from 14% in 2007 to 79% by 2015 ...

8.

publications.ersnet.org

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

Effectiveness and safety of endobronchial ultrasound ...

Comparing all results with those based on surgical staging, the sensitivity for detecting malignancy was 89% and NPV was 98.9%. Wallace et al. 19 are ...