Brain TumorPhase 2P5ANCT06678867
The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours
A Phase 2 study testing 5-ALA (Gliolan) in people with Brain Tumor, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- 5-ALA (Gliolan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2025to 30 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Brain Tumor
- Being tested
- 5-ALA (Gliolan)
- Keywords
- Ependymoma, Glioma, Paediatric, 5-ALA, Brain tumour
- Medical subject headings
- Brain Neoplasms, Ependymoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ALA (Gliolan)Drug
Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with high grade brain tumours | Other | This is a single-arm study with two cohorts Receives: Drug: 5-ALA (Gliolan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours.
Timeframe between informed consent and surgery
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start25 Mar 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase II, multicentre, non-randomised open-label trial with two cohorts.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678867
- Sponsor's protocol ID
- UCL/154416
- Other IDs
- CCLGA 2022 27 Dandapani
- Acronym
- P5A
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following data protection guidance