NCT06678867Not yet recruitingPhase 2
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 · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 25 Mar 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University College, London
- Diseases
- Childhood cancers
- NCT number
- NCT06678867
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 25 Mar 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to the active substance or to porphyrins
- History of light sensitivity reactions
Other
- 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
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nottingham Children's Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.