Intraoperative fluorescence in meningioma surgery
- Conditions
- Surgical candidates with supratentorial meningiomasTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-003230-32-AT
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Concomitant inclusion into another clinical trial.
Previous operation in same location (recurrence).
Porphyria.
Renal failure.
Liver disease.
Known hypersensitivity to 5-ALA.
Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.