The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours

Inclusion criteria

• Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour
• Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours
• Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement
• 3 - 18 years inclusive
• Adequate liver and kidney function

• creatinine - less than one and a half times the upper limit of normal.
• haemoglobin above the lower limit of normal
• Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal
• bilirubin lower than one and a half times the upper limit of normal
• Normal Coagulation profile

o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits

• Urine porphyrin - Test to be completed and sent for analysis
• Blood pressure lower than or equal to the upper limit of normal
• Negative pregnancy test in women of childbearing potential*
• Informed Consent *A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient

Exclusion criteria

• Patients with low grade tumours (either radiological or histological diagnosis)
• Patient is appropriate for biopsy only, based on Investigator and MDT judgement
• Known history (including family history) of porphyria
• Hypersensitivity to the active substance or to porphyrins
• History of light sensitivity reactions
• Pregnant or breastfeeding women