Clinical trial · Interventional
Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective, open, single-armed, multicenter, phase II study for application of 5-ALA in children and adolescents with brain tumors 80 patients will be investigated. Primary objective of the study is to determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with intra-axial brain tumors. Secondary objectives are * to determine whether fluorescent tissue truly signifies tumor (positive predictive value) in various pediatric brain tumors * to determine the degree of tumor resection on early post-operative MRI * and to determine the pharmacokinetics of 5-ALA in this population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor, Pediatric | Childhood Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic Acid Hydrochloride, Oral | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-Aminolevulinic Acid (5-ALA)
- description
- Application of 5-ALA oral solution followed by fluorescence-guided brain tumor resection
- interventionNames
- Drug: 5-Aminolevulinic Acid Hydrochloride, Oral
Primary outcomes (1)
- measure
- Safety of 5-ALA for fluorescence-guided resections in children and adolescents determined as incidence of adverse events of CTCAE grade III-V.
- timeFrame
- up to 6 weeks after tumor resection
- description
- Incidence of adverse events of CTCAE grade III, IV or V (excluding chemotherapy-associated toxicities) during and after 5-ALA fluorescence-guided resections in children and adolescents
Secondary outcomes (5)
- measure
- True positive rate of fluorescence for indicating tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available