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

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