Status:
COMPLETED
Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors
Lead Sponsor:
Universität Münster
Collaborating Sponsors:
photonamic GmbH & Co. KG
medac GmbH
Conditions:
Brain Tumor, Pediatric
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
In 2007, 5-aminolevulinic acid (5-ALA) was approved in Europe by the European Medicines Agency (EMA) (brand name: Gliolan®) for "the visualization of malignant tissue during surgery for malignant glio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04738162
Start Date
September 25 2020
End Date
November 24 2025
Last Update
December 10 2025
Active Locations (7)
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1
Universitätsklinikum Augsburg, Klinik für Neurochirurgie
Augsburg, Germany, 86146
2
Universitätsklinikum Essen, Klinik für Neurochirurgie
Essen, Germany, 45147
3
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurochirurgie
Mainz, Germany, 55131
4
Neurochirurgische Klinik der Universität München (LMU)
München, Germany, 81377