Surgical candidates with supratentorial meningiomas
Conditions
Interventions
Trade Name: gliolan
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: 5-ALA HCl
CAS Number: 5451-09-2
Other descriptive name: AMINOLEVULINIC ACID HYDROCHLORIDE
Concentrati
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female, aged 18 to 85 years. Radiological diagnosis (MRI) of a supratentorial meningioma. Surgical candidate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Concomitant inclusion into another clinical trial. Previous operation in same location (recurrence). Porphyria. Renal failure. Liver disease. Known hypersensitivity to 5-ALA. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Positive intraoperative determination of malignant meningioma cells through protoporphyrin IX fluorescence after oral administration of 5-aminolevulinic acid (gliolan®) ;Secondary Objective: Not applicable;Primary end point(s): Positive fluorescence in malignant meningioma cells.;Timepoint(s) of evaluation of this end point: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Austria
Contacts
Public ContactUniv.Klinik für Neurochirurgie
Medizinische Universität Graz
Outcome results
None listed