Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).

• Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.

• First operation of the tumour, no other tumour-specific pretreatment

• Karnofsky at least 70 %

• Patient's written informed consent

• Age 18-72 years

Exclusion Criteria:

• Tumour location in the midline, basal ganglia, cerebellum or brain stem

• More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases

• Porphyria, hypersensitivity to porphyrins

• Renal insufficiency: Creatinine > 2.0 mg/dl

• Hepatic insufficiency: Bilirubin > 3 mg/dl

• Quick test < 60 %

• gamma-GT > 70 U/I

• Malignancies other than basaliomas

• Existing or planned pregnancy or lactation, or inadequate contraception

• Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation