Study on Fluorescence-Guided Surgery Using cRGD-ZW800-1 for Patients with Laryngeal and Hypopharyngeal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma that affects the larynx and hypopharynx, which are parts of the throat. The study is exploring a new treatment method using a special medication called cRGD-ZW800-1. This medication is a fluorescent tracer, which means it helps doctors see the cancer more clearly during surgery by making it glow under certain lights.

The purpose of the study is to find out if this fluorescent method can help surgeons better identify and remove cancerous tissue during a surgery called a total laryngectomy or pharyngectomy. This is a procedure where the affected parts of the throat are removed. The study will involve giving the medication through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The goal is to see if the glowing effect can help doctors distinguish cancerous tissue from healthy tissue more effectively.

Participants in the study will receive the medication before their surgery, and doctors will use a special camera to see the glowing effect during the operation. The study will help determine if this method is practical and useful for improving the accuracy of cancer surgeries in the throat area. The trial is expected to continue until the end of 2025, with recruitment starting in late 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include having a biopsy-proven squamous cell carcinoma of the larynx or hypopharynx, being eligible for surgical removal of the tumor, being at least 18 years old, and having sufficient knowledge of the Dutch language to understand the informed consent form.

2 preparation for surgery

Before the surgery, the patient will receive an intravenous infusion of a substance called cRGD-ZW800-1. This is a special dye used to help visualize the cancer during surgery. The infusion is administered directly into the bloodstream through a vein.

3 surgery with fluorescence imaging

During the surgery, a technique called fluorescence imaging is used. This technique helps the surgical team to see the cancer more clearly by making it glow under a special light. The goal is to identify the cancerous tissue more accurately and ensure that it is removed completely.

4 post-surgery evaluation

After the surgery, the effectiveness of the fluorescence imaging is evaluated. This involves measuring the tumor-to-background ratio (TBR), which indicates how well the cancer was distinguished from surrounding tissues. A TBR greater than 1.5 is considered feasible.

5 follow-up

The study will continue to monitor the patient’s recovery and the success of the surgery in terms of clear resection margins, which means that no cancerous tissue is left behind.

Who Can Join the Study?

Patients must have a confirmed diagnosis of squamous cell carcinoma of the larynx or hypopharynx. This means they have a specific type of cancer in the throat area.
Patients should be eligible for surgery to remove the tumor. This means the doctors have determined that surgery is a possible treatment option for them.
Patients must be 18 years of age or older.
Patients need to provide written informed consent. This means they agree to participate in the study after understanding what it involves.
Patients must have enough knowledge of the Dutch language to understand the consent form. This ensures they fully understand what they are agreeing to.

Who Cannot Join the Study?

Patients who do not have squamous cell carcinoma of the larynx or hypopharynx cannot participate. This type of cancer affects the voice box and the area just above the esophagus.
Patients who are not undergoing a total laryngectomy or pharyngectomy are excluded. These are surgeries to remove the voice box or the area around it.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

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Site Name	City	Country	Status
Ecbpeyc Ucgnqufciwzr Mgtyqnp Cglutwb Rsamfipod (ztfikai Myu	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Crgd-Zw800-1

Fluorescence-guided surgery: This is a technique used during surgery to help doctors see cancerous tissues more clearly. A special dye is injected into the body, which makes the cancer cells glow under a specific type of light. This helps the surgeon to identify and remove cancerous tissues more accurately, potentially improving the outcomes of the surgery. In this trial, the technique is being tested for its feasibility in surgeries for laryngeal and hypopharyngeal cancer.

Investigated diseases:

Squamous cell carcinoma of the hypopharynx

Squamous Cell Carcinoma of the Larynx and Hypopharynx – This is a type of cancer that begins in the squamous cells, which are thin, flat cells lining the larynx and hypopharynx. The larynx, also known as the voice box, and the hypopharynx, the lower part of the throat, are critical for breathing, speaking, and swallowing. As the disease progresses, it can cause symptoms such as a persistent sore throat, difficulty swallowing, and changes in voice. The cancer may grow locally and can potentially spread to nearby tissues and lymph nodes. Early stages might not show noticeable symptoms, making it challenging to detect without medical examination. Over time, the tumor can become more invasive, affecting the function of the larynx and hypopharynx.

Trial ID:

2024-519750-36-00

Protocol code:

NL74742.078.20

Trial Phase:

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

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Study on Fluorescence-Guided Surgery Using cRGD-ZW800-1 for Patients with Laryngeal and Hypopharyngeal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?