brain tumors
Conditions
Interventions
Single administration of 5-ALA prior to planned resection
Sponsors
Universität Münster
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Age 3 -
Exclusion criteria
Exclusion criteria: - Extra-axial tumors such as craniopharyngeoma. - 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 bilirubine > 2x ULN, serum γ-GT > 2,5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 ULN. - Blood clotting: INR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicological and clinical safety by measuring the 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 with unifocal, contrast-enhancing intra-axial brain tumors, (first diagnosis with unknown histology, recurrent with malignant neuroepithelial histology). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. True positive rate of fluorescence for indicating tumor. 2. Extent of resection as assessed on early post-operative MRI 3. Pharmacokinetics (determination of protoporphyrin IX 3 times within 12h after 5-ALA administration) | — |
Countries
Netherlands
Outcome results
None listed