AuthorisedTherapeutic exploratory (Phase II)Interventional

An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) in combination with transoral robotic surgery for oropharyngeal squamous cell carcinoma and neck dissection surgery for oral squamous cell carcinoma with regional lymph node metastases

This study is testing a special glow-in-the-dark dye, called FG001, to see if it can help surgeons find cancer more easily during operations. It focuses on two types of cancer: mouth cancer that has spread to neck glands, and a type of throat cancer called oropharyngeal squamous cell carcinoma. For throat cancer, the aim is to see how well FG001 can highlight the main tumour during robotic surgery. For mouth cancer, the study wants to check if the dye can pinpoint cancer cells in the neck glands. By making cancer cells more visible, surgeons hope to remove all of them, which could lead to better outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rigshospitalet

Enrolment target

Start

08 Jun 2026

Oral Squamous Cell Carcinoma with neck metastases, Oropharyngeal Squamous Cell Carcinoma

What is this study about?

This study is looking at a new way to help surgeons find and remove cancer during operations. When someone has certain types of mouth or throat cancer, it's really important for surgeons to remove all the cancer cells. Sometimes, small areas of cancer can be hard to see.

Researchers are using a special dye, called FG001. After a patient receives this dye, they will have their surgery. The idea is that the dye will stick to cancer cells and make them glow under a special light, helping the surgeon see exactly where the cancer is. By making the cancer easier to spot, surgeons hope to remove it more completely than they might be able to using standard methods.

Specifically, for some patients with throat cancer (oropharyngeal squamous cell carcinoma) having robotic surgery, the study will check if FG001 helps highlight the main tumour. For others with mouth cancer that has spread to glands in the neck (regional lymph nodes), the study will see if the dye can accurately show which neck glands have cancer. The main goal is to see how good this dye is at lighting up the cancer, comparing it to what doctors find when they look at the removed tissue under a microscope.

Key takeaways

This study uses a special dye to help surgeons find cancer during operations.
It's for specific types of mouth and throat cancer.
The dye aims to make cancer cells glow, improving visibility.
The goal is to help surgeons remove all cancer more effectively.
Your standard surgery will still take place, with the dye assisting the surgeon.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

You would be considered for this study if you have been diagnosed with either oropharyngeal squamous cell carcinoma (a type of throat cancer) and are scheduled for a specific robotic surgery to remove the primary tumour, or if you have oral squamous cell carcinoma (a type of mouth cancer) that has spread to the lymph nodes in your neck and you are planned for surgery to remove these neck nodes.

Your medical team will check other specific details about your health and your cancer to make sure this study is right for you and that taking part would be safe.

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 at least 18 years old?
Have you been diagnosed with oropharyngeal squamous cell carcinoma and are planned for specific robotic surgery?
OR, have you been diagnosed with oral squamous cell carcinoma that has spread to neck lymph nodes and are planned for neck surgery?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you would receive the special dye, FG001, usually before your planned surgery. During your operation, the surgeons would use special equipment to look for areas that light up, helping them to see the cancer. They will then perform your surgery as planned.

After your surgery, doctors will look very closely at the tissue that was removed to see how well the dye worked at highlighting the cancer. There will likely be follow-up appointments, but these would largely be part of your standard cancer care. The study aims to see how effective the dye is during a single surgery. The total duration of your active participation related specifically to the dye would be around your surgery day and immediate follow-up related to tissue analysis.

Potential risks and benefits

Participating in this study might offer a potential benefit if the dye helps your surgeon remove your cancer more completely. However, it's also possible that the dye won't work as expected. As with any medical procedure or substance, there could be some risks or side effects from receiving the FG001 dye. These would be explained in detail before you decide to join. You are always free to change your mind and 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
Denmark

Common questions

What is FG001?

FG001 is a special dye designed to make cancer cells glow during surgery, helping doctors see them better.

What kind of cancer is this study for?

It's for a type of throat cancer called oropharyngeal squamous cell carcinoma, and a type of mouth cancer that has spread to the neck.

Will I have a different surgery if I join?

No, you will have your planned surgery. The dye is used to help surgeons during that surgery, not to change the type of operation.

What happens after the dye is given?

The dye is usually given before your surgery. During the operation, special cameras are used to see if the cancer lights up.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.