Clinical trial · Interventional
The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours
A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-ALA (Gliolan) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with high grade brain tumours
- description
- This is a single-arm study with two cohorts
- interventionNames
- Drug: 5-ALA (Gliolan)
Primary outcomes (1)
- measure
- Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours.
- timeFrame
- Two weeks
- description
- Timeframe between informed consent and surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available