Study on Improving Oral Cancer Surgery Using cRGD-ZW800-1 Fluorescent Imaging for Patients with Oral Cancer

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What is this study about?

This clinical trial focuses on improving the surgical removal of oral cancer using a special technique called fluorescence imaging. Oral cancer refers to cancer that occurs in the mouth, and the goal of this study is to make sure that the cancer is removed more completely during surgery. The treatment being tested is a new medication called cRGD-ZW800-1, which is given through an intravenous infusion. This medication helps doctors see the cancer more clearly during surgery by making it glow under a special light.

The purpose of the study is to find the best dose of cRGD-ZW800-1 that will make the cancer stand out the most from the surrounding healthy tissue. This will help surgeons remove the cancer with a clear margin, meaning they take out a small amount of healthy tissue around the cancer to ensure all cancer cells are removed. The study will also look at how well this technique works in identifying cancer that has spread to nearby lymph nodes.

Participants in the study will receive the cRGD-ZW800-1 medication before their surgery. During the operation, the surgeon will use the fluorescence imaging technique to guide the removal of the cancer. The study will monitor how well the cancer is removed and how much extra tissue is taken out based on the imaging. The study aims to improve the success of oral cancer surgeries and reduce the chances of cancer coming back.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of squamous cell carcinoma of the oral cavity and ensuring the patient is eligible for surgical removal of the primary tumor.

Eligibility criteria include being 18 years or older and providing written informed consent.

2 preparation for treatment

Before the surgical procedure, preparation involves planning the use of cRGD-ZW800-1, a fluorescent imaging agent.

The agent is administered through an intravenous infusion to help visualize the tumor during surgery.

3 administration of cRGD-ZW800-1

The cRGD-ZW800-1 is given via an intravenous infusion. The dosage is determined to achieve the highest tumor-to-background ratio, which is a measure of how well the tumor can be distinguished from surrounding tissue.

The goal is to achieve a ratio of at least 1.5, which helps in identifying the tumor more clearly during surgery.

4 surgical procedure

During the surgery, real-time fluorescence imaging is used to guide the removal of the tumor. This technology helps ensure that the tumor is adequately removed with clear margins of more than 5mm.

The use of fluorescence imaging aims to improve the accuracy of the surgery and reduce the likelihood of leaving cancerous tissue behind.

5 post-surgical evaluation

After the surgery, the removed tissue is evaluated to confirm the adequacy of the resection margins.

Additional assessments include analyzing the sensitivity and specificity of the imaging, as well as the operation time and any extra tissue resection based on the imaging results.

6 follow-up

Follow-up appointments are scheduled to monitor recovery and assess the outcomes of the surgery.

The study aims to complete by July 2025, with ongoing evaluations to ensure the effectiveness and safety of the procedure.

Who Can Join the Study?

Patients must have oral cancer, specifically a type called squamous cell carcinoma, which has been confirmed by a biopsy. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined under a microscope.
Patients must be eligible for surgery to remove the main tumor.
Patients must be 18 years of age or older.
Before joining the study, patients must provide written informed consent. This means they agree to participate after being fully informed about the study, following international and local guidelines.

Who Cannot Join the Study?

Patients who are not diagnosed with oral cancer cannot participate. Oral cancer refers to cancer that occurs in the mouth.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Epfupuv Uycpjbkatymj Mtdyvcy Cjsngrh Rrzepehys (ccoazot Mzm	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.07.2022

Trial locations

cRGD-ZW800-1 is a special imaging agent used in this trial to help surgeons see oral cancer more clearly during surgery. It works by making the cancer cells light up, which helps doctors remove the tumor more accurately and ensure that they leave a safe margin around it. This can help improve the chances of removing all the cancerous tissue while preserving as much healthy tissue as possible.

Investigated diseases:

Oral neoplasm

Oral Cancer – Oral cancer refers to cancer that develops in any part of the mouth, including the lips, gums, tongue, inner lining of the cheeks, roof of the mouth, and floor of the mouth. It typically begins as a growth or sore that does not heal. As it progresses, it may cause persistent mouth pain, difficulty swallowing, and changes in speech. The disease can spread to nearby tissues, including lymph nodes in the neck. Early stages might not show significant symptoms, making regular dental check-ups important for detection. The progression can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-512824-13-01

Protocol code:

NL71347.078.20

NCT ID:

NCT04191460

Trial Phase:

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

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Study on Improving Oral Cancer Surgery Using cRGD-ZW800-1 Fluorescent Imaging for Patients with Oral Cancer

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