Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.

This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.

Inclusion Criteria:

• Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
• Indication for craniotomy for removal of a suspected or recurrent brain tumor
• Karnofsky Performance Scale >/- 60%

Exclusion Criteria:

• Prophyria, hypersensitivity to porphyrins
• Renal insufficiency as defined per protocol
• Hepatic insufficiency as defined per protocol
• Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
• Nursing women or women using inadequate contraception