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

medac GmbH21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Brain Neoplasm

Interventions

GliolanBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Within 3 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.