Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

Study Overview
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Brief Summary
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This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

Official Title
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Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

Conditions
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Brain Neoplasm

Intervention / Treatment
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* Biological: Gliolan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis) Indication for surgical tumour resection First operation of the tumour, no other tumour-specific pre-treatment Karnofsky Performance Scale 70% Patient's written informed consent Age 18-75 years Exclusion Criteria: Porphyria, hypersensitivity to porphyrins Renal insufficiency: Creatinine > 2.0 mg/dl Hepatic insufficiency: Bilirubin > 3 mg/dl Quick test < 60 % GT > 100 U/I Other known malignancy (except basaliomas) Women: Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom) Men: Inadequate contraception (condom) Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent Simultaneous participation or participation in another clinical trial in the preceding 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose level 1<br>0,2 mg/Kg | Biological: Gliolan<br> <br> * Other names: 5-Aminolevulinic Acid Hydrochloride (5-ALA);|
| Active Comparator: Dose level 2<br>2,0 mg/Kg | Biological: Gliolan<br> <br> * Other names: 5-Aminolevulinic Acid Hydrochloride (5-ALA);|
| Active Comparator: Dose level 3<br>20 mg/Kg | Biological: Gliolan<br> <br> * Other names: 5-Aminolevulinic Acid Hydrochloride (5-ALA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma). | After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically. | Within 3 hours |