Who can enter
- Children diagnosed with neuroblastoma, determined by the doctor, who need surgery to remove the tumor
- Age: 1-18 years old
Goal
The goal of this study is to investigate whether anti-GD2-800CW is safe and which dose works best to visualize neuroblastoma during surgery.
Background
Neuroblastoma is a type of cancer that develops in nerve cells. It can occur in different places in the body, but it is common in the abdomen (80%). Operating on neuroblastomas is difficult for the surgeon. If the surgeon removes too much tissue, problems may arise and healthy organs may not work as well as they should. If the surgeon removes too little tissue, the disease may come back. So far, the surgeon uses his eyes and hands to see if the tissue is malignant, but this is not always possible. Therefore, there is a need for a new technique that can help see the tumor better during surgery.
In this study, we are investigating whether a special technique can be used during surgery to make neuroblastoma more visible. This technique is called fluorescence-guided surgery. It requires a substance that binds to the tumor cells and lights up when illuminated with a special camera. This technique has already been proven to make tumors more visible in adults. For this study, we have developed such a substance, called anti-GD2-800CW. This substance has two parts: an antibody, called dinutuximab (anti-GD2), which is already used to treat neuroblastoma in children, and a fluorescent substance, IRDye800CW, which has been found to be safe in adults. This is the first time we are using this combined substance in children with neuroblastoma. We want to know how safe this substance is and whether it helps to make the tumor visible during surgery.
The children receive the usual treatment for neuroblastoma. Four days before surgery, the children come to the hospital for an additional appointment to receive the anti-GD2-800CW via intravenous infusion. They stay in the hospital for up to 24 hours for the administration. If all goes well, they can go home after 24 hours and come back one day before surgery.
The dose is first started at 1 mg/m2 (adjusted to body weight). If this is safe, the dose is increased to 2 and 3 mg/m2 in groups of three patients. The group receiving the best dose will be expanded, up to a maximum of ten patients. In total, up to 22 patients will participate in the study. The doctors will follow the patients closely and check for side effects, and they will perform blood tests and a physical examination.
During surgery, a special camera is used to look at the tumor to see how well anti-GD2-800CW works. The patient will not notice any of this. The surgeon will look at the tumor with the camera and indicate whether the tumor is visible or not with the camera. After surgery, the tissue is examined by the pathologist to see if it was malignant or not. Pictures and videos will be taken of the tissue to compare the images later. As this is a study, the surgeon will not use this information to make decisions.
It is difficult to completely remove neuroblastoma with current techniques. The substance anti-GD2-800CW helps to make the tumor more visible so that it can be removed more easily. The low dose of anti-GD2, along with the safe experience with IRDye800CW, ensures that the risks are small. Patients also receive pain relief to reduce side effects.
The advantage of this technique is that it can help improve tumor removal and treatment of neuroblastoma. This may be especially useful for children who now have a poor prognosis.