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

Sponsor
University College, London
Study ID
NCT06678867
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-ALA (Gliolan) — DRUG
    Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery

Study Details

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.

Key Dates

First listed
Nov 7, 2024
Start date
Mar 25, 2025
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Patients with high grade brain tumours
    This is a single-arm study with two cohorts

Primary Outcome Measure

Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours. [ Time Frame: Two weeks ]

Central Contacts

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