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

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

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.

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