The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours (P5A)

March 24, 2025 updated by: University College, London

A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom
        • Nottingham Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with high grade brain tumours
This is a single-arm study with two cohorts
Drug: 5-ALA (Gliolan)
Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Timeframe between informed consent and surgery
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL/154416
  • CCLGA 2022 27 Dandapani (Other Grant/Funding Number: Little Princess Trust- Children's Cancer and Leukaemia Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Following data protection guidance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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