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A Study Testing Cetuximab with Fluorescent Dye to Help Surgeons See Cancer Edges During Surgery in Patients with Oral Squamous Cell Carcinoma

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What is this study about?

This study is looking at oral squamous cell carcinoma, which is a type of cancer that affects the mouth. The treatment being investigated involves using cetuximab, which is a type of medicine called a monoclonal antibody. In this study, the cetuximab has been specially modified by attaching a fluorescent dye called IRDye800CW to it. This modification allows the medicine to make cancer cells glow under special light during surgery, which may help surgeons see the edges of the tumor more clearly.

The purpose of this study is to improve how surgeons identify the edges of tumors during surgery and to test whether using fluorescence-guided surgery can help detect tumor margins better in patients with head and neck cancer. The study will compare the surgical results of patients who receive this fluorescence-guided approach with those who receive standard surgical care. The medicine will be given through a vein as an injection or infusion before the surgery takes place.

During the study, patients will undergo their planned surgical removal of the tumor, but the surgical team will use special imaging equipment that can detect the fluorescent signal from the modified cetuximab. This helps the surgeon see whether all the cancer has been removed by looking at the glowing edges during the operation. The study will also look at how well this method works by measuring its accuracy in identifying areas where cancer cells might remain at the surgical margins. Additionally, the study will test a new imaging technique and evaluate how information can be shared between the pathology laboratory and the surgical team during the operation to improve decision-making.

1 Confirmation and enrollment

Your diagnosis of oral squamous cell carcinoma (a type of cancer in the mouth) has been confirmed through laboratory tests.

The treatment team has decided that surgical removal of the tumor is the appropriate treatment for your condition.

You have provided written informed consent to participate in this clinical trial.

2 Pre-surgery preparation

You will receive cetuximab, which is a medication given through a vein in your arm.

This medication will be administered as an intravenous infusion, meaning it will be slowly delivered into your bloodstream through a needle placed in a vein.

The medication is designed to help identify tumor tissue during your surgery using a special imaging technique.

3 Surgical procedure

You will undergo surgery to remove the tumor from your mouth as planned by your treatment team.

During the operation, the surgical team will use fluorescence imaging, a technique that uses special light to help visualize the tumor and its edges more clearly.

This imaging technique helps the surgeon determine the boundaries of the tumor and assess whether all cancerous tissue has been removed.

The pathologist (a doctor who examines tissue samples) will provide feedback to the surgical team during the operation about the tumor margins (the edges of the removed tissue).

4 Tissue analysis

The removed tissue will be examined by the pathology department to determine the margin status, which means checking whether the edges of the removed tissue are free of cancer cells.

The fluorescence imaging results will be compared with the standard laboratory examination of the tissue.

This comparison helps determine how accurate the fluorescence imaging technique is in identifying tumor boundaries.

5 Post-surgery assessment

Your surgical outcome will be assessed, focusing on whether clear margins were achieved (meaning all cancer cells were removed with healthy tissue surrounding them).

The results from the fluorescence imaging technique used during your surgery will be evaluated and compared to standard surgical methods.

Your treatment team will discuss the results with you and determine any further treatment that may be needed based on the findings.

Who Can Join the Study?

  • You must have a confirmed diagnosis of oral squamous cell carcinoma, which is a type of cancer that occurs in the mouth. This diagnosis must be confirmed through cytology, which is the examination of cells under a microscope, or through histology, which is the examination of tissue samples under a microscope.
  • You must be scheduled to have surgery to remove the cancer, and this surgery must be recommended by the team of doctors who specialize in treating head and neck cancers.
  • You must be at least 18 years old or older.
  • You must provide written informed consent, which means you agree in writing to participate in the study after being fully informed about what it involves.

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • If you are interested in participating, the research team would need to provide you with complete information about who cannot take part in this study
  • Generally, clinical trials have specific requirements about medical history, other treatments, and health conditions that may prevent participation, but these details are not available in the provided information

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ushkayrgftip Mnoldfn Czhqfrg Gldbneaqa Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.02.2026

Trial locations

Investigated drugs:

Fluorescence imaging agent is used during surgery to help doctors see the edges of cancerous tissue more clearly. This special dye makes cancer cells glow under certain light, which helps surgeons identify where the tumor ends and healthy tissue begins. This allows the surgical team to remove the cancer more completely while preserving as much healthy tissue as possible.

Investigated diseases:

Oral Squamous Cell Carcinoma – This is a type of cancer that develops in the mouth from the flat, thin cells that line the oral cavity. The disease begins when these cells start to grow abnormally and uncontrollably, forming a tumor. It typically starts as a small patch or sore that may appear white, red, or mixed in color on the tongue, gums, floor of the mouth, or other oral tissues. As the cancer progresses, the tumor can grow larger and invade deeper into surrounding tissues. The disease may spread to nearby lymph nodes in the neck and potentially to other parts of the body. Without intervention, the cancer continues to grow and can affect eating, speaking, and other important functions.

Trial ID:
2025-522027-95-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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