Glowing tumor surgery: new hope for kids with brain cancer?
NCT ID NCT04738162
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 Hide 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
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Prinses Máxima Centrum voor kinderoncologie BV
Utrecht, 3584, Netherlands
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University Hospital Münster, Klinik für Neurochirurgie
Münster, 48149, Germany
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Universitätsklinikum Augsburg, Klinik für Neurochirurgie
Augsburg, 86146, Germany
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Universitätsklinikum Essen, Klinik für Neurochirurgie
Essen, 45147, Germany
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Universitätsklinikum Tübingen, Klinik für Neurochirurgie
Tübingen, 72076, Germany
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Universitätsmedizin Mainz, Klinik und Poliklinik für Neurochirurgie
Mainz, 55131, Germany
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