RecruitingPHASE2INTERVENTIONAL

Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery

This study is investigating a new way to help surgeons remove head and neck cancers more completely. It uses a special dye called indocyanine green (ICG) and a camera that sees in near-infrared light. During surgery, after the main tumour has been removed, the doctors will use this system to check for any tiny cancer cells that are too small to see with the naked eye. The goal is to make sure all cancer cells are taken out, which could help prevent the cancer from coming back. This is a Phase 2 study, meaning it’s an early stage where doctors are testing how well this new method works.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

Start

15 Dec 2020

Estimated completion

01 Nov 2026

Head and Neck Cancer

What is this study about?

This study is looking at a new technique to help doctors treat head and neck cancers. When someone has surgery for cancer, the surgeon tries to remove all of the tumour. However, sometimes there can be very small cancer cells left behind that are impossible to see without special help. These leftover cells, called 'microscopic residual disease', can sometimes lead to the cancer coming back.

This new technique involves a special dye called indocyanine green (ICG). This dye glows when it's seen with a specific near-infrared camera. The idea is that if cancer cells take up this dye differently, or in a way that makes them glow in the camera, the surgeon could then see these otherwise invisible cells. This could help them remove every last bit of the cancer during surgery, improving the chances of a successful outcome.

By using this glowing dye and camera system during the operation, after the main visible tumour has been removed, doctors hope to get a clearer picture of whether any tiny cancer cells have been missed. This could potentially make the surgery more effective and reduce the need for further treatments later on.

Key takeaways

This study uses a special dye and camera during head and neck cancer surgery to find hidden cancer cells.
The goal is to help surgeons remove all cancer cells, even very tiny ones, to improve treatment success.
It's for people with certain types of head and neck cancer that can be removed by surgery.
The dye (indocyanine green) and camera system are new tools being tested in this early-stage study.
Participation involves receiving the dye during surgery and follow-up care for your cancer.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older with head and neck cancer that doctors believe can be fully removed by surgery. You also need to have a specific type of head and neck cancer called squamous cell carcinoma, located in your mouth or the back of your throat (oral cavity or oropharynx).

There are also some important things that would mean you couldn't take part. For example, if you have other serious health problems, if your cancer has spread to other parts of your body, or if you've had head and neck cancer or radiation treatment for it in the last five years. Women who are pregnant or breastfeeding, or who have certain allergies (especially to iodine or shellfish), would also not be able to join.

The study also checks that you don't have certain other health conditions, like severe kidney or heart disease, or an overactive thyroid. It's important that you understand what the study involves and are happy to give your permission to take part.

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 head and neck squamous cell cancer in your mouth or throat that can be surgically removed?
Do you *not* have other serious medical problems, or have cancer that has spread?
Are you *not* pregnant or breastfeeding, and do not have an allergy to iodine or shellfish?
Have you *not* had head and neck cancer or radiation for it in the last 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a meeting with the study team to make sure it's right for you and to explain everything. If you are a woman of childbearing age, you would also need a pregnancy test before getting the dye.

During your cancer surgery, you would receive the special indocyanine green (ICG) dye. The doctors would then use the special near-infrared camera system to look for any hidden cancer cells after they've removed the main tumour. There isn't a fixed number of visits mentioned, but you would have regular follow-up appointments after your surgery as part of your normal cancer care, during which your health and recovery would be monitored.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a more thorough surgical removal of your cancer, which could improve your chances of a successful long-term outcome. However, as with any medical procedure, there are potential risks associated with the dye and the surgery itself, which your doctor will explain fully. The dye can cause allergic reactions in some people, so checks are made beforehand. You will be closely monitored by the medical team throughout. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Institut Jules Bordet
Verified postcode
Anderlecht, Belgium· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is indocyanine green (ICG)?

ICG is a special medical dye that doctors can use to see things inside your body more clearly, especially with a camera that sees a certain type of light (near-infrared).

What is 'near-infrared imaging'?

This is a special camera system that can see a type of light that isn't visible to the human eye. When combined with the ICG dye, it can help highlight certain areas, like tiny cancer cells.

Why is this study important?

It's important because if surgeons can see and remove all cancer cells during an operation, even the tiny ones, it could help prevent the cancer from coming back and improve patient outcomes.

Will I know if I'm getting the dye or not?

Yes, everyone in this study will receive the indocyanine green (ICG) dye as part of the new technique being tested during surgery.

How long will I be in the study?

The study involves a procedure during your existing head and neck cancer surgery, and then likely follow-up as part of your standard care. The full duration isn't specified but your doctor can give you more details.

How to find out more

Philippe Gorphe, MD

philippe.gorphe@gustaveroussy.fr +33 (0)1 42 11 42 11 Official trial record

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