RecruitingPHASE1INTERVENTIONAL

Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

This study is testing a new method for removing small lung cancers in patients with non-small cell lung cancer. Traditionally, surgeons remove an entire lobe of the lung, but this new technique aims to remove only the cancerous segment. This saves more healthy lung tissue. The study uses a special dye called indocyanine green (ICG) with robotic surgery. The dye helps the surgeon clearly see the cancerous segment, making the surgery more precise. The goal is to make it easier for surgeons to perform a segmentectomy, which is a less invasive type of lung surgery, ensuring patients have the best possible outcome.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

St. Joseph's Healthcare Hamilton

Enrolment target

250

Start

01 Oct 2016

Estimated completion

01 Dec 2026

Non-small Cell Lung Cancer

What is this study about?

When someone has an early-stage lung cancer, especially smaller tumours, doctors often recommend surgery. The usual surgery is called a lobectomy, where an entire section (or 'lobe') of the lung is removed. This works well, but it means taking out a lot of healthy lung tissue too. Recently, doctors have been looking for ways to be more precise, especially when the cancer is very small. They've found that sometimes, only a smaller part of the lobe, called a 'segment,' needs to be removed. This less extensive surgery is called a segmentectomy, and it's great because it leaves more of your healthy lung intact.

However, performing a segmentectomy, especially with robotic surgery, can be tricky. It's hard for the surgeon to clearly see the exact edges of the segment that needs to come out while looking at screens during the operation. This can sometimes lead to surgeons performing a lobectomy even when a segmentectomy might have been enough. This study aims to make segmentectomy easier and more accurate for patients having robotic surgery.

The study uses a special dye called indocyanine green (ICG) along with the robotic surgery system. Here's how it works: first, the surgeon uses scans to pinpoint the exact segment with the tumour. Then, during surgery, they temporarily stop the blood flow to just that segment. After this, the ICG dye is injected into your bloodstream. The dye makes all the parts of your lung that still have blood flow glow green under a special camera. The segment with the tumour, which had its blood flow temporarily stopped, won't glow, appearing 'dark'. This allows the surgeon to clearly see and remove only the non-glowing, affected segment. After the surgery, pathologists will check the removed tissue to make sure all the cancer is gone. If, for any reason, they find that some cancer might have been missed, the surgeon will then perform the usual lobectomy to make sure all cancer is removed, prioritising your safety.

Key takeaways

This study explores a new, more precise surgery for early lung cancer.
It aims to remove only the cancerous part of the lung, saving more healthy tissue.
A special dye helps surgeons see the exact area to remove during robotic surgery.
The surgery is called a segmentectomy, a less extensive operation than a lobectomy.
Patient safety is a top priority; if needed, the standard surgery will be performed.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 or older. Your lung cancer should be an early-stage type called Non-Small Cell Lung Cancer, and the tumour itself needs to be relatively small, less than 3 centimetres.

Doctors also need to see from your CT scans that your tumour is clearly contained within just one of the smaller sections of your lung, called a broncho-pulmonary segment. This is important because the surgery aims to remove only this specific segment.

There are a few reasons why you might not be able to join. If you've had an allergic reaction before to the dye (indocyanine green), or to substances like sodium iodide or iodine, then this study wouldn't be suitable for you. Also, if you are pregnant, breastfeeding, or could become pregnant and are not using reliable contraception, you wouldn't be able to participate.

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 Non-Small Cell Lung Cancer?
Is your tumour small (less than 3cm)?
Does your doctor's scan show the tumour is in just one specific segment of your lung?
Are you NOT allergic to indocyanine green, sodium iodide, or iodine?
Are you NOT pregnant or breastfeeding, and if you could become pregnant, are you using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have your usual check-ups, including discussions with your doctor and scans, to confirm you meet the study requirements. The main part of your participation will be the robotic surgery itself. Before the surgery, you'll have all the standard preparations. During the surgery, a special dye called indocyanine green (ICG) will be injected into your bloodstream. This is a one-time injection during the operation to help the surgeon. After the surgery, you'll recover as you normally would from lung surgery. The study doesn't involve extra hospital visits or long-term follow-up beyond what your regular care would require after lung cancer surgery. The total duration of your active participation, specifically for the study intervention, is limited to the time of your surgery.

Potential risks and benefits

Participating in this study might offer the benefit of undergoing a segmentectomy, which could allow you to keep more healthy lung tissue compared to a traditional lobectomy. This could potentially improve your breathing and overall lung function after surgery. However, there are potential risks, including those associated with any surgery, like bleeding or infection. There's also a small risk of an allergic reaction to the special dye. The study protocol ensures your safety: if the pathologist finds that the tumour wasn't fully removed in the segmentectomy, a regular lobectomy will be performed to make sure all the cancer is gone. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

St. Joseph's Healthcare Hamilton
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to find a better, more precise way to remove small lung cancers using robotic surgery, by helping surgeons clearly see the tumour area and save healthy lung tissue.

What is a 'segmentectomy'?

A segmentectomy is a type of lung surgery where only a small part of a lung lobe (called a segment) is removed, rather than the whole lobe, saving more healthy lung.

What is indocyanine green (ICG) and how is it used?

ICG is a special dye injected during surgery that helps the surgeon see the different parts of your lung more clearly under a special camera, making it easier to remove the cancerous section.

What happens if this new surgery doesn't remove all the cancer?

Don't worry, a pathologist will check the removed tissue during the operation. If they find any cancer might have been missed, the surgeon will then perform the standard lobectomy to ensure all the cancer is gone.

Will I have to pay for anything if I join this study?

Clinical trials generally cover the costs associated with the study's specific interventions, but it's important to discuss this with the study team as standard medical care costs may still apply.

How to find out more

Lisa L Patterson, BA

patterls@stjoes.ca 905-522-1155 Official trial record

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