RecruitingNAINTERVENTIONAL

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)

This study focuses on people with early-stage lung cancer who aren't able to have surgery. It investigates a gentle procedure called Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA). This test helps doctors check if cancer cells have spread to the lymph nodes (small glands) in the chest. Knowing this information accurately is very important because it helps doctors decide if a specific type of advanced radiation therapy, called Stereotactic Body Radiotherapy (SBRT), is the best treatment option. SBRT is a powerful and very focused radiation treatment. The study wants to see if using EBUS-TBNA before SBRT helps people get the right treatment and if it leads to good outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

150

Start

01 Feb 2013

Estimated completion

01 Dec 2027

Lung Cancer

What is this study about?

When someone is diagnosed with early-stage lung cancer, it's very important for doctors to understand if the cancer has spread from the main tumour to nearby lymph nodes, which are small glands that are part of your body's immune system. This information helps doctors decide on the best treatment plan for you. For some people, surgery might not be an option, perhaps due to age, other health conditions, or lung problems.

In these cases, a modern and very precise radiation treatment called Stereotactic Body Radiotherapy (SBRT) can be very effective. However, SBRT is only suitable if the cancer hasn't spread to these nearby lymph nodes. This study is looking at a special test called Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, often shortened to EBUS-TBNA. It's a gentle procedure where doctors use a thin, flexible tube with an ultrasound camera and a tiny needle to take small samples from the lymph nodes in your chest.

The main goal of this study is to see how well EBUS-TBNA works in accurately checking these lymph nodes for cancer cells. If the test shows the nodes are clear, patients can then go on to have the SBRT treatment. By using this precise test, doctors can make sure that people who can't have surgery but are suitable for SBRT get the right treatment, potentially leading to better outcomes for them.

Key takeaways

This study is for patients with early lung cancer who can't have surgery.
It uses a gentle test, EBUS-TBNA, to check if cancer has spread to lymph nodes.
Accurate results help decide if a specialized radiation (SBRT) is right for you.
SBRT is a powerful, non-surgical treatment for certain lung cancers.
Participation means undergoing EBUS-TBNA and receiving SBRT if eligible.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with non-small cell lung cancer that only affects an early stage in your lungs (meaning it hasn't spread widely). You should also be someone for whom surgery is not an option, perhaps due to other health issues, or because you have decided not to have surgery. Before joining, doctors would have already checked your lungs with CT and PET scans.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have certain infections that are active. You also can't participate if you are planning to have other cancer treatments like regular chemotherapy, other types of radiation, or surgery (unless it's for the cancer getting worse later on). Also, if you're not well enough overall for a bronchoscopy procedure, or if you are unable to give your consent to take part, you cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have early-stage lung cancer (non-small cell type)?
Have doctors said surgery isn't suitable for you?
Have you already had CT and PET scans for your lungs?
Are you not pregnant or breastfeeding, and don't have active infections?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a discussion with a specialist doctor (a thoracic surgeon, radiation oncologist, or medical oncologist) to confirm that surgery is not the right path for you. You will already have had CT and PET scans. The main part of your participation is undergoing the EBUS-TBNA procedure. This is done at Toronto General Hospital by a thoracic surgeon. It involves local anaesthesia (numbing medicine) and a medicine to help you relax and feel sleepy, but you'll still be partly awake (conscious sedation).

During the procedure, the surgeon will check the lymph nodes in your chest and take small samples using a tiny needle. These samples will be sent to a lab to check for cancer cells. If your lymph nodes are clear, you will then proceed with Stereotactic Body Radiotherapy (SBRT) for your lung cancer. After your treatment, the doctors will look at your medical records to see how you are doing over time. The study duration varies based on your treatment and follow-up.

Potential risks and benefits

Taking part in this study could offer you the benefit of an accurate diagnosis for your lymph nodes using a less invasive method than traditional surgery, helping to determine if the highly effective SBRT is the right treatment for your early-stage lung cancer. This could lead to a good outcome without needing a major operation. As with any medical procedure, there are potential risks with the EBUS-TBNA, such as discomfort, a slight risk of bleeding, infection, or a collapsed lung, though these are rare. You will be closely monitored, and your doctors will explain all specific risks. Remember, taking part in any study is entirely voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is EBUS-TBNA?

It's a gentle test using a thin tube with a camera and tiny needle to check lymph nodes in your chest for cancer cells, avoiding open surgery.

What is SBRT?

SBRT is a highly focused and powerful type of radiation therapy used to treat early-stage lung cancer, especially when surgery isn't an option.

Why is this study important?

It helps ensure people who can't have surgery get the right treatment (SBRT) by accurately checking if their cancer has spread to nearby glands.

Will I be awake during the EBUS-TBNA?

You'll have local numbing medicine and also medication to help you relax and feel sleepy, but you'll be partly awake (conscious sedation).

What happens after the EBUS-TBNA?

If your lymph nodes are clear, you'll likely receive SBRT for your lung cancer. Doctors will then monitor your progress.

How to find out more

Judy McConnell

judy.mcconnell@uhn.ca Official trial record

Always speak to your GP or specialist before deciding to take part in a study.