Clinical Trial Finder

Inclusion Criteria:

• - Age 3 - <18 years.

• - First radiological diagnosis of intra-axial, supratentorial contrast-enhancing tumor on MRI or recurrent supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, atypical teratoid rhabdoid tumors (AT/RT), Oligodendroglioma, etc.) - Resection is part of therapeutic strategy with an emphasis on neurological safety.

• - Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study.

Patients that are able to understand should provide assent to participate in the trial.

• - Female adolescents: not pregnant (pregnancy test required for adolescents of child-bearing age) and not breast-feeding (for at least 24 hours after Gliolan intake).

Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.

Exclusion Criteria:

• - Posterior fossa tumors.

• - Extra-axial tumors such as craniopharyngioma.

• - Germ cell tumor or entities precluding surgical resection.

• - Acute or chronic porphyria.

• - Hypersensitivity to 5-ALA or porphyrins.

• - Renal insufficiency: serum creatinine > 2x upper limit of normal (ULN) - Hepatic insufficiency: serum bilirubin > 2x ULN, serum γ-glutamyl transferase > 2,5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 ULN.

• - Blood clotting: INR (international normalized ratio) out of acceptable limits.

• - Other malignant disease.

• - Patients with pre-existing cardiovascular diseases.

- Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) - Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration

In 2007, 5-aminolevulinic acid (5-ALA) was approved in Europe by the European Medicines Agency (EMA) (brand name: Gliolan®) for "the visualization of malignant tissue during surgery for malignant glioma (WHO III and IV) in adults." Similarly, approval for 5-ALA was granted by the FDA in 2017 as an "optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery" (brand name: Gliolan®). Goal of the study is to investigate if the use of 5-ALA is safe in children and get preliminary information on the type of paediatric brain tumors which are suitable for fluorescence-guided resection with 5-ALA.

Arms

Experimental: 5-Aminolevulinic Acid (5-ALA)

Application of 5-ALA oral solution followed by fluorescence-guided brain tumor resection

Interventions

Drug: - 5-Aminolevulinic Acid Hydrochloride, Oral

Application of 5-ALA oral solution (20mg/kg bw) 4 hours (range 3.5-4.5 hours) prior to anesthesia followed by fluorescence-guided tumor resection Tumor resection is performed conventionally using a surgical microscope. A change from white light to blue light is possible at anytime to make the fluorescence visible