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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06678867
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University College, London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor
Arms & Interventions

Arms

Other: Patients with high grade brain tumours

This is a single-arm study with two cohorts

Interventions

Drug: - 5-ALA (Gliolan)

Gliolan 30 ml/mg powder for oral solution, Single dose 3-6 hours prior to surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nottingham Children's Hospital, Nottingham, United Kingdom

Status

Address

Nottingham Children's Hospital

Nottingham, ,

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