intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.) MedDRA version: 20.0 Level: LLT Classification code 10006154 Term: Brain tumor NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gliolan 30mg/ml
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 5-AMINOLEVULINIC ACID
CAS Number: 106-60-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Personal und Recht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 3 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Extra-axial tumors such as craniopharyngeoma • Tumors precluding surgical resection • Acute or chronic porphyria • Hypersensitivity to 5-ALA or porphyrins • Renal insufficiency: serum creatinine > 2x upper limit of normal • Hepatic insufficiency: serum bilirubine > 2x upper limit of normal, serum ?-GT > 2,5 x upper limit of normal, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 upper limit of normal • 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 |
|---|---|
| Main Objective: To determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with intra-axial brain tumors;Secondary Objective: 1. To determine whether fluorescing tissue truly signifies tumor (positive predictive value) 2. To determine extent of tumor resection on early post-operative MRI 3. Pharmacokinetics of 5-ALA in children and adolescents;Primary end point(s): 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 history, recurrent with malignant neuroepithelial histology) ;Timepoint(s) of evaluation of this end point: Adverse events will be documented continuously from day of operation to 6 weeks afterwards. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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);Timepoint(s) of evaluation of this end point: 1. Biopsies are taken during the resection of the tumor 2. MRI is done until max. 72h post-OP 3. Samples for protoporphyrine IX analysis will be taken 3-6h, 6-9h, 9-12h after 5-ALA administration | — |
Countries
Germany, Netherlands
Contacts
Public ContactKlinik für Neurochirurgie
Universitätsklinikum Münster
Outcome results
None listed