Brain Tumor
Conditions
Keywords
Ependymoma, Glioma, Paediatric, 5-ALA, Brain tumour
Brief summary
The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour. Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.
Interventions
DRUG5-ALA (Gliolan)
Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery
Sponsors
University of Nottingham
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a phase II, multicentre, non-randomised open-label trial with two cohorts.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours. | Two weeks | Timeframe between informed consent and surgery |
Countries
United Kingdom
Contacts
Primary ContactPaed 5-ALA Trial Manager
Outcome results
None listed