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Safety Study of 5-Aminolevulinic Acid for Brain Tumor Surgery in Children and Adolescents

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on children and adolescents with brain tumors. The study will evaluate the safety of a medicine called 5-Aminolevulinic acid (5-ALA), available as Gliolan, which comes as a powder that is mixed with liquid and taken by mouth. This medicine helps surgeons see tumor tissue more clearly during brain surgery by making the tumor cells glow under special light.

The main purpose of this research is to determine if 5-ALA can be safely used for surgery in young patients when removing tumors from the brain. During the study, patients will receive a single dose of the medication before their scheduled brain surgery. The medicine is given at a dose based on the patient's body weight, up to 20 milligrams per kilogram.

After taking the medicine, patients will undergo brain surgery where doctors will use special lighting to help them see and remove the tumor tissue. The study will monitor patients for any side effects or complications that may occur during and after the surgery. Some patients may also have blood samples taken to understand how the medicine works in young bodies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Pre-surgery preparation

    You will receive Gliolan, an oral solution containing 30 mg/ml of a substance called aminolevulinic acid hydrochloride

    This medication helps surgeons better see tumor tissue during the operation

    If you are a female of childbearing age, a pregnancy test will be required before participation

  2. Step 2

    Surgery day

    The surgical team will perform a fluorescence-guided resection of your brain tumor

    During surgery, the medical team will take tissue samples from areas that show fluorescence

    The surgeon will document any fluorescent areas that cannot be safely removed

  3. Step 3

    Post-surgery monitoring

    You will be monitored for any side effects or complications for 24 hours after taking Gliolan

    An MRI scan will be performed shortly after the surgery to assess the results

    If you have provided consent, three blood samples will be collected within 12 hours after receiving Gliolan

  4. Step 4

    Follow-up period

    If you are of reproductive age, you must use effective birth control for 6 weeks after the operation

    The medical team will monitor your recovery and document any significant health changes

    Your participation in the study will contribute to understanding how this medication works in young patients with brain tumors

Who can join the trial?

9 criteria

  • Age between 3 and 17 years old
  • Must have either:
    • A first-time diagnosis of a brain tumor visible on MRI (magnetic resonance imaging) that shows contrast enhancement, or
    • A returning brain tumor (such as malignant glioma, astrocytoma, malignant ependymoma, AT/RT, or oligodendroglioma)
    • Surgery must be considered a safe treatment option from a neurological perspective
    • Must have parental or guardian consent, and when possible, the patient's agreement to participate after being informed about the study's purpose and risks
    • For female participants:
      • Must not be pregnant (pregnancy test required for teens who can become pregnant)
      • Must not be breastfeeding for at least 24 hours after taking Gliolan
      • For sexually active participants:
        • Must use effective birth control methods for up to 6 weeks after the tumor surgery
        • This applies to both male and female participants

Who cannot join the trial?

11 criteria

  • Patients who are younger than 2 years old
  • Patients who are allergic to 5-ALA (a substance used to make brain tumors visible during surgery)
  • Patients with severe liver problems
  • Patients with severe kidney problems
  • Patients with porphyria (a rare inherited blood disorder that affects how the body makes red blood cells)
  • Pregnant or breastfeeding women
  • Patients who have taken part in another clinical trial in the past 30 days
  • Patients who are unable to follow study procedures
  • Patients with known hypersensitivity (severe allergic reactions) to any component of the study medication
  • Patients who cannot undergo brain surgery
  • Patients who have conditions that could interfere with the study results
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Investigated drugs

5-Aminolevulinic acid (5-ALA) is a naturally occurring compound that helps surgeons better visualize brain tumors during surgery. When given to patients before surgery, it causes tumor cells to glow pink under special blue light. This helps doctors distinguish between healthy brain tissue and tumor tissue, making the surgery more precise. The medication is taken by mouth before the surgical procedure.

What is already known about the treatment

5-Aminolevulinic acid (5-ALA) - A naturally occurring compound administered orally before brain surgery that helps surgeons better visualize tumor tissue during operation. This substance, when taken by mouth, accumulates selectively in tumor cells and produces a fluorescent pink-red glow under special blue light during surgery, making it easier for surgeons to distinguish between healthy and cancerous brain tissue. 5-ALA belongs to the class of diagnostic imaging agents and is currently being studied in clinical trials for its safety in children and adolescents with various types of brain tumors, though it has already been approved for use in adults. The compound works by entering the heme biosynthesis pathway, where it is converted to protoporphyrin IX, which accumulates in tumor cells and produces fluorescence under specific lighting conditions.

Investigated diseases

  • Brain tumor

    A condition where abnormal cells grow and multiply within the brain tissue. Brain tumors can be either primary (starting in the brain) or secondary (spreading from other parts of the body). These growths can develop in different areas of the brain and can be slow-growing or aggressive. Brain tumors can affect brain function by pressing on surrounding tissues, causing swelling, or interfering with normal brain activity. The specific symptoms depend on the tumor's location and size within the brain. As tumors grow, they can cause changes in the pressure inside the skull.

  • Intra-axial brain tumor

    A type of brain tumor that develops within the brain tissue itself, rather than on the outside of the brain. These tumors grow within the substance of the brain and can affect various regions. Intra-axial tumors can arise from different types of brain cells and may be located in any part of the cerebral hemispheres, brainstem, or cerebellum. They can cause various symptoms depending on their specific location within the brain tissue.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-517575-20-00Protocol codeUKM2013_0034Estimated enrolment51 patientsSponsorUniversitaet Muenster

sourced from the EU Clinical Trials Register and site verification

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This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).