Not recruiting

Study on Using Cetuximab with Fluorescence Endoscopy to Find Primary Tumors in Patients with Unknown Head and Neck Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with a condition known as unknown primary tumor of the head and neck. This means that cancer has spread to the head and neck area, but the original source of the cancer is not known. The study aims to find the primary cancer site using a special technique called targeted fluorescence endoscopy. This method involves using a fluorescent tracer, which is a substance that lights up under certain conditions, to help doctors see the cancer more clearly. In this study, the tracer used is called cetuximab-800CW, which is a modified version of a medication known as Erbitux.

The purpose of the study is to see if this new method can help identify the primary tumor in the upper part of the throat and digestive tract. Participants will undergo a procedure where the fluorescent tracer is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. After the tracer is administered, doctors will use a special camera to look for the glowing areas that might indicate the presence of cancer. This process is expected to help in locating the primary tumor that was not found during standard tests like physical exams, X-rays, or CT scans.

The study will observe how well the tracer works in highlighting cancerous areas and will compare these findings with traditional methods. It will also collect information about the participants, such as their age, sex, and medical history, to understand how these factors might affect the results. The study will also assess the quality of life of participants before and after the procedure to ensure their well-being. The trial is expected to continue until the end of 2026, with the aim of improving the detection of primary tumors in patients with this challenging condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing written informed consent.
Eligibility is confirmed based on a diagnosis of squamous cell carcinoma likely originating from the head and neck area, with the primary tumor not identified during standard diagnostic procedures.
Step 2
Preparation for endoscopy
Scheduled for an endoscopy of the upper aerodigestive tract as determined by a multidisciplinary head and neck tumor board.
Preparation involves understanding the procedure and any necessary pre-procedure instructions.
Step 3
Administration of fluorescent tracer
Receive an intravenous infusion of Erbitux 5 mg/mL solution, which contains the active substance cetuximab.
Cetuximab is used as a fluorescent tracer to help identify primary tumors during the endoscopy.
Step 4
Targeted fluorescence endoscopy
Undergo a targeted fluorescence endoscopy (TFE) to detect the primary cancer lesion.
The procedure aims to identify primary tumors in the upper aerodigestive tract using the fluorescent tracer.
Step 5
Post-procedure evaluation
Assessment of macroscopic fluorescent signal levels and tracer distribution.
Detection rates of TFE and white light endoscopy (WLE) are evaluated.
Step 6
Additional assessments
Patient characteristics such as age, sex, and medical history are recorded.
Quality of life is assessed using specific questionnaires.
Step 7
Follow-up
Regular follow-up appointments may be scheduled to monitor health and gather further data.
The study is estimated to conclude by December 31, 2026.

Who can join the trial?

4 criteria

The patient must have a confirmed diagnosis of **squamous cell carcinoma**, which is a type of cancer, most likely starting in the head and neck area. The patient should be scheduled for a procedure called **endoscopy** of the upper part of the throat and digestive tract, as decided by a team of specialists.
The main tumor was not found during the usual tests done in the clinic, which include a physical exam of the head and neck, a special camera test called **fiberoptic laryngoscopy**, and imaging tests like chest X-ray, **CT**, and **PET/CT** scans.
The patient must be **18 years or older**.
The patient must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with an unknown primary tumor of the head and neck cannot participate. This means the main source of the cancer in the head and neck area is not identified.
Patients who are not within the specified age range cannot participate. The study is open to adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Universitair Medisch Centrum Groningen
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Groningen, The Netherlands

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Investigated drugs

Cetuximab-800CW is a special type of medication used in this clinical trial. It is a fluorescent tracer, which means it helps doctors see certain areas more clearly during an endoscopy. In this study, it is used to help identify primary tumors in the upper part of the throat and digestive tract in patients who have cancer that has spread but whose original tumor location is unknown.

Cetuximab

What is already known about the treatment

Cetuximab-800CW – This medication is administered through targeted fluorescence endoscopy, a method used to detect primary cancer lesions in patients with unknown primary tumors in the head and neck. Currently, it is being studied in clinical trials to assess its feasibility and effectiveness in identifying these tumors. The main therapeutic indication is for patients with metastasis of unknown primary tumors in the head and neck region. Cetuximab-800CW works by binding to specific proteins on cancer cells, allowing them to be visualized using fluorescence, which helps in locating the primary tumor. It is classified as a monoclonal antibody used in cancer detection.

Investigated diseases

Unknown Primary Tumor of the Head and Neck – This condition involves the presence of cancerous cells in the head and neck region, where the original site of the tumor cannot be identified. It typically presents with symptoms such as swollen lymph nodes, pain, or difficulty swallowing. The disease progresses as cancer cells spread to nearby tissues or lymph nodes, often without clear signs of the primary tumor. This can make it challenging to determine the exact origin of the cancer, complicating the understanding of its progression. The focus is often on identifying the primary site to better understand the disease's behavior.