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
- Are there results?
- Not yet: the study is under way
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.
Show all 15Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours
- ClinicalTrials.gov ID
- NCT06678867
- Acronym / sponsor ID
- P5A / UCL/154416
- Conditions
- Brain Tumor
- Keywords
- Ependymoma, Glioma, Paediatric, 5-ALA, Brain tumour
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase II, multicentre, non-randomised open-label trial with two cohorts.
| Arm | Type | Receives |
|---|---|---|
| Patients with high grade brain tumours | Other | Drug: 5-ALA (Gliolan)This is a single-arm study with two cohorts |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-ALA (Gliolan)Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery | Drug | Patients with high grade brain tumours |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. Following data protection guidance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-ALA (Gliolan) in people with Brain Tumor, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paed 5-ALA Trial Manager (020 7679 9860, ctc.paed5-ala@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.