AuthorisedTherapeutic confirmatory (Phase III)Interventional

Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation

This research study is for people who have a type of mouth cancer called oral squamous cell carcinoma. The main goal is to compare a new surgical technique against the usual one. The new technique uses a special dye called Cetuximab and a glowing light (fluorescence imaging) during surgery. This helps surgeons see if they've removed all the cancer, aiming to leave no cancer cells behind. The study will see if this new method improves how much cancer is removed compared to current practice. Researchers will also look at how well this glowing light method works and explore new imaging techniques. It's for adults aged 18 and over, both men and women.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

120

Start

19 Jan 2026

oral squamous cell carcinoma

What is this study about?

Imagine you're having surgery for mouth cancer, and the surgeon wants to make sure every single cancer cell is removed. This study, called "Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer," is looking at a new way to help them do just that.

Currently, surgeons rely on their eyes and feel, and sometimes send tiny bits of tissue to a lab to check if the edges (called "margins") of the removed tissue are clear of cancer. This new method uses a special dye called Cetuximab. This dye is given to the patient, and it's designed to stick to cancer cells. Then, during surgery, a special light is used, and the dye makes any remaining cancer cells glow. This glowing helps the surgeon see if any tiny bits of cancer are still there, allowing them to remove them immediately.

The main aim of this study is to see if using this glowing dye technique helps surgeons remove all the cancer more effectively than the standard way. This is very important because leaving even a few cancer cells behind can mean the cancer might come back. The study will also carefully check how good this new glowing method is at finding cancer cells and will compare it with older ways of using this technology to see if there are even better ways to use it in the future. It's a key step in making surgery for mouth cancer as successful as possible.

Key takeaways

This study explores a new method to help surgeons remove all mouth cancer cells.
It uses a special dye (Cetuximab) and light to make cancer cells glow during surgery.
The goal is to improve surgical outcomes and reduce the chances of cancer returning.
The study is for adults with oral squamous cell carcinoma.
It compares this new technique with the usual surgical approach.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The specific type of cancer you need to have is called oral squamous cell carcinoma, which is a type of mouth cancer. The research will be looking closely at how effective the new surgical approach is for this particular condition.

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 a type of mouth cancer called oral squamous cell carcinoma?
Are you male or female?
Are you able to understand and consider the information about the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have discussions with the study team to ensure it's right for you. If you qualify and agree, you would receive the special dye, Cetuximab, as part of the new surgical approach. During your surgery for mouth cancer, the medical team would use a special light to see if any cancer cells glow, guiding the surgeon in real-time.

The study aims to compare this new method with the standard way, so some participants might receive the usual care. After surgery, you would have follow-up appointments, just like anyone recovering from cancer surgery, to check on your health and recovery. The study will not add extra visits beyond what would normally be needed for your care. The total duration of your involvement would depend on your recovery and the standard follow-up schedule for your cancer, but the special part of the study happens during and immediately after surgery.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the new technique might help ensure all the cancer is removed during your surgery, potentially reducing the chance of it coming back. However, it's also important to remember that this is a research study, and there's no guarantee the new method will be better than standard care. You might experience side effects from the Cetuximab dye, although these will be carefully monitored. You have the right to withdraw from the study at any time without affecting your 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 mouth cancer?

Mouth cancer, or oral squamous cell carcinoma, is a type of cancer that starts in the cells that line the mouth.

What is Cetuximab?

Cetuximab is a medication sometimes used in cancer treatment. In this study, it's used as a special dye to help doctors see cancer cells.

Will I definitely get the new treatment?

This study compares the new method with standard care. You might receive the new method or the standard treatment, depending on what the study design decides for you.

How will the doctors see the cancer cells?

After you receive the special dye, a unique light is used during surgery. This light makes any cancer cells attached to the dye glow, making them easier to spot.

Will this study change my recovery after surgery?

The study aims to improve the surgery itself. Your recovery and follow-up care after surgery would be similar to what is usually expected for mouth cancer treatment.