AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging

This research is investigating a new technique to improve how oral (mouth) cancer is removed during surgery. Surgeons often find it difficult to see the exact edges of the cancer. This study uses a special substance called cRGD-ZW800-1, which, when combined with a special light, makes cancer cells glow. The main goal is to see if this 'glowing' guidance helps surgeons remove all the cancer, leaving a clear area around it (a good margin). This could mean fewer second operations for patients and better chances of recovery. This is the first time this method is being tested in humans.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

17 Dec 2024

Oral cancer

What is this study about?

Imagine you have a small stain on a tablecloth, and you want to cut it all out without cutting too much extra fabric. That's a bit like what surgeons face when removing cancer. It can be hard to tell exactly where the cancer stops and healthy tissue begins.

This study, called "Guided by Light," is testing a new tool to help surgeons see the edges of oral cancer more clearly during an operation. They will use a special dye (called cRGD-ZW800-1) that attaches itself to cancer cells. When a special light is shined on the area, the cancer cells that have taken up the dye will glow. This glowing light acts like a guide for the surgeon, helping them to be more precise in removing the cancer.

The main aim is to see if using this glowing dye helps surgeons remove all the cancer in one go, leaving a healthy border (at least 5mm) around where the tumour was. If successful, this could mean better results for patients, potentially reducing the need for further surgery, and ensuring as much cancer as possible is removed from the start.

Key takeaways

This study is testing a new way to help surgeons remove oral cancer more completely.
It uses a special substance that makes cancer cells glow under a specific light.
The goal is to ensure all cancer is removed in one surgery, leaving clear margins.
This is the first time this method is being tested in humans.
Participation involves receiving the substance during surgery and follow-up visits.

Who may be eligible?

This study is open to adults aged 18 and older, both men and women, who have been diagnosed with oral cancer.

More specific details about your health and the type of oral cancer you have would be checked by the study doctors to see if this particular treatment is right for you. They will need to ensure it's safe for you to take part.

Patients who have other serious health problems, have had certain previous treatments, or are pregnant or breastfeeding would likely not be able to participate. Your doctor can discuss your individual situation.

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?
Have you been diagnosed with oral cancer?
Are you able to attend appointments at the study hospital?
Are you generally in good health apart from your cancer diagnosis?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have several tests to make sure the study is right for you. These might include blood tests, scans, and a review of your medical history.

During your cancer surgery, you would receive the special cRGD-ZW800-1 substance, which helps the cancer glow. The surgeons would then use a special light to guide them during the operation. They will be watching closely to see if the glowing helps them remove all the cancer with clear margins.

After your surgery, you would have follow-up visits. The doctors would examine the tissue removed to see how well the glowing technique worked, and they'd monitor your recovery and overall health. The exact number of visits and the total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part include the possibility of having your cancer removed more completely in one go, which could improve your long-term outlook. However, this is a new treatment being tested for the first time in humans, so there may be unknown risks or side effects from the special substance or the light. The study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is oral cancer?

Oral cancer is cancer that develops in any part of the mouth, including the lips, tongue, cheeks, floor of the mouth, hard and soft palate, and throat.

What does 'guided by light' mean?

It means using a special glowing substance and a special light during surgery to help the surgeon see the cancer cells more clearly, making it easier to remove them completely.

What is the study hoping to find out?

The study wants to see if this 'glowing' technique helps surgeons remove all of the cancer with a safe, clear border of healthy tissue around it, reducing the chance of needing another operation.

Is this a new treatment?

Yes, this is the first time this specific 'glowing' substance is being used in people during oral cancer surgery.

Will I have to pay to be in the study?

No, all study-related treatments and tests are covered by the research study.

How to find out more

Official trial record

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