Central Nervous System Tumor, Pediatric Clinical Trial
Official title:
The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric CNS Tumors
Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas,
ependymomas, medulloblastomas, and many other pathologies.
In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while
preserving neurological function. Extent of tumor residual has been shown to be a major
prognostic factor for progression free survival (PFS), and survival in several malignant and
low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors.
5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of
various cancers. Following oral admission, during surgery, the tumor tissue is illuminated
by blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX
(PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This
enables the surgeon to better identify tumor cells and perform a more extensive resection.
Over recent years, many studies have proven the efficacy using 5-ALA for resecting various
intracranial and spinal tumors, thus achieving a better tumor control.
In the suggested study, we propose using the same technique for various pediatric central
nervous system tumors.
We will focus on the correlation between various pathologies and the fluorescence, trying to
deduce the role of 5-ALA in resection of specific pathologies.
Also, we will study the safety of 5-ALA use in the pediatric population.
Following the above general description, eligible children will receive 5-aminolevulinic
acid (5ALA) prior to surgery.
During surgery, careful attention will be payed to the fluorescence from the tumor, as well
as the ability to differentiate between tumor and non tumorous tissue.
Comparisons between fluorescence and pathologies will be performed. Additionally, careful
documentation of side effects will be done, to increase the safety of 5ALA use.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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