Study of Anti-GD2-800CW for Imaging in Children with Neuroblastoma

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What is this study about?

This clinical trial is focused on studying neuroblastoma, a type of cancer that most commonly affects children. The trial is testing a new treatment called Anti-GD2-800CW, which is a solution for injection. This treatment is designed to help doctors see the cancer more clearly during surgery by using a special fluorescent imaging technique. The main goal of the study is to find the best dose of Anti-GD2-800CW that is both safe and effective for children with neuroblastoma.

Participants in the study will receive the Anti-GD2-800CW treatment through an intravenous infusion, which means it will be given directly into a vein. The study will monitor how the treatment works in the body and how well it helps in identifying cancer cells during surgery. Researchers will also keep track of any side effects that might occur from the treatment. The study aims to ensure that the treatment is safe and that it helps surgeons to better distinguish between cancerous and healthy tissues during operations.

The trial will take place over several months, with participants undergoing regular check-ups and tests to monitor their health and the effectiveness of the treatment. Blood samples will be collected at different times to understand how the treatment is processed by the body. The study will also evaluate how visible the cancer is during surgery when using the Anti-GD2-800CW treatment, helping to improve surgical outcomes for children with neuroblastoma.

1 joining the study

Upon joining the study, the patient will have already provided written informed consent, either personally or through a parent or legal guardian, as required by local laws and regulations.

The patient must be diagnosed with neuroblastoma and be between the ages of 1 and 18 years.

2 preparation for treatment

Before receiving the treatment, a blood sample will be taken to establish a baseline. This is referred to as t=0, which means just before the infusion begins.

3 administration of anti-GD2-800CW

The patient will receive an IV infusion of the anti-GD2-800CW solution. This is a special imaging agent designed to help visualize the tumor during surgery.

The infusion is part of the study to determine the recommended dose and to assess the safety of the agent.

4 monitoring after infusion

After the infusion, blood samples will be collected at several time points: directly after the infusion (t=8h), 24 hours after (t=24h), 72 hours after (t=72h), immediately before surgery (t=96h), 24 hours after surgery (t=120h), 48 hours after surgery (t=144h), and 4 days after surgery (t=192h).

These samples help to understand how the body processes the imaging agent.

5 surgery

The patient will undergo surgery as part of their standard care for neuroblastoma.

During surgery, the effectiveness of the imaging agent will be assessed by its ability to help surgeons distinguish between the tumor and surrounding tissue.

6 post-surgery evaluation

After surgery, the removed tissue will be examined to compare the fluorescent signal with the actual tumor cells.

The visibility of the fluorescence during surgery will be scored by surgeons to determine how well the imaging agent worked.

Who Can Join the Study?

Patients must have a diagnosis of neuroblastoma, which is a type of cancer, confirmed by a medical test called histopathology.
Patients must be scheduled for surgery to treat neuroblastoma as part of their standard medical care.
Patients must be older than 1 year and not older than 18 years.
Written permission, known as informed consent, must be given by the patient and/or their parents or legal guardians, following local laws and rules.

Who Cannot Join the Study?

Patients who do not have neuroblastoma cannot participate. Neuroblastoma is a type of cancer that most often affects children.
Patients who are not within the specified age range for the study cannot participate. The study is for children.
Patients who are not able to provide informed consent or do not have a legal guardian to provide consent cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a previous allergic reaction to similar treatments cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments recently that might interfere with the study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.02.2025

Trial locations

Investigated drugs:

ANTI-GD2-800CW

Anti-GD2-800CW is a special imaging agent used in this clinical trial for patients with neuroblastoma, a type of cancer that mostly affects children. This agent is designed to help doctors see the cancer more clearly during imaging tests. It works by attaching to a specific marker found on the cancer cells, which makes them light up under a special camera. This helps doctors to better understand the extent of the cancer and plan the best treatment approach. The trial aims to find the best dose of this imaging agent that is both safe and effective for use in children.

Investigated diseases:

Neuroblastoma

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and arises from immature nerve cells in various parts of the body. It typically begins in the adrenal glands, which are located on top of the kidneys, but can also develop in the neck, chest, abdomen, or spine. The disease progresses as the cancer cells grow and form a mass or tumor, which can spread to other areas of the body, including lymph nodes, bones, bone marrow, liver, and skin. As neuroblastoma advances, it may cause symptoms such as abdominal pain, a lump in the abdomen, or bone pain. The progression can vary significantly, with some tumors growing slowly and others rapidly. The disease is known for its potential to spontaneously regress in some cases, particularly in very young children.

Trial ID:

2023-507596-22-00

Protocol code:

SP_PS21DIN

Trial Phase:

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

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Study of Anti-GD2-800CW for Imaging in Children with Neuroblastoma

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