Who can enter
- Children with a tumor in the cerebrum (supratentorial brain tumor), who have not received previous treatment or in whom the disease has recurred.
- Age: 3 to 17 years old.
This study is now closed for inclusion.
Goal
The purpose of the study is to investigate the safety of 5-aminolevulinic acid (Gliolan ® from Medac; 5-ALA) in children. Furthermore, we will examine whether 5-ALA can be used in children to make tumor tissue more visible during surgery. Finally, we will investigate how quickly 5-ALA is broken down by a child's body.
Background
With many brain tumors, surgery is part of the treatment. To maximize the chance of healing, it is important that a tumor is removed as completely as possible. This involves trying to remove as little healthy tissue as possible.
5-ALA is a drug that can make tumor tissue light up under blue light (fluoresce). This makes tumor tissue more distinguishable from healthy tissue during surgery. 5-ALA has been studied in adults with brain tumors. In patients who had received 5-ALA before surgery, tumor tissue could be removed more completely than in patients who had not received 5-ALA. Also, patients who received 5-ALA were less likely to have a recurrence (relapse) or worsening of the disease (progression).In addition, adult patients experienced few side effects from 5-ALA. 5-ALA has therefore been approved in adults with brain tumors to better visualize tumor tissue during surgery.
Brain tumors in children often consist of different cells than brain tumors in adults. In this study, we therefore want to see if 5-ALA can also be used safely in children. We will also investigate which type(s) of brain tumors in children can be made more visible with 5-ALA and how quickly 5-ALA is broken down again by the body. Because we are currently not sure whether 5-ALA causes only the tumor tissue to fluoresce in children, the surgeon performs the operation under normal light. The removed tissue is then also viewed under blue light.