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Glowing tumor surgery: new hope for kids with brain cancer?

NCT ID NCT04738162

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called 5-ALA in 78 children with brain tumors. The drug makes tumor cells glow under a special light during surgery, helping surgeons remove more of the tumor while avoiding healthy brain. The main goal was to check if the drug is safe for children. Researchers also looked at how well the glow identifies tumor tissue and how much tumor could be removed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-Aminolevulinic acid (5-ALA) oral solution
What this could lead to
If successful, this could make brain tumor surgery safer and more precise for children, helping surgeons remove more tumor while sparing healthy brain tissue.
What could go wrong
This is a small, early-phase safety study (Phase 2) with no control group. The drug may cause side effects, and it is not yet proven to improve long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 3 - \<18 years * First radiological diagnosis of intra-axial, contrast-enhancing tumor on MRI or recurrent supratentorial intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, atypical teratoid rhabdoid tumors (AT/RT), Oligodendroglioma, etc.) * Resection is part of therapeutic strategy with an emphasis on neurological safety * Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial * Female adolescents: not pregnant (pregnancy test required for adolescents of child-bearing age) and not breast-feeding (for at least 24 hours after Gliolan intake). Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Exclusion Criteria: * Extra-axial tumors such as craniopharyngioma * Entities precluding surgical resection * Acute or chronic porphyria * Hypersensitivity to 5-ALA or porphyrins * Renal insufficiency: serum creatinine \> 2x upper limit of normal (ULN) * Hepatic insufficiency: serum bilirubin \> 2x ULN, serum γ-glutamyl transferase \> 2,5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST)\> 2,5 ULN * Blood clotting: INR (international normalized ratio) out of acceptable limits * Other malignant disease * Patients with pre-existing cardiovascular diseases * Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) * Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Neurochirurgische Klinik der Universität München (LMU)

    München, 81377, Germany

  • Prinses Máxima Centrum voor kinderoncologie BV

    Utrecht, 3584, Netherlands

  • University Hospital Münster, Klinik für Neurochirurgie

    Münster, 48149, Germany

  • Universitätsklinikum Augsburg, Klinik für Neurochirurgie

    Augsburg, 86146, Germany

  • Universitätsklinikum Essen, Klinik für Neurochirurgie

    Essen, 45147, Germany

  • Universitätsklinikum Tübingen, Klinik für Neurochirurgie

    Tübingen, 72076, Germany

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Neurochirurgie

    Mainz, 55131, Germany

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