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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Glioma; Brain Tumor

Treatments: Device: Orbeye surgical videomicroscope; Drug: 5-Aminolevulinic Acid

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04055688

MCC-20014

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Participants with known or suspected high grade gliomas

Treatment:

Drug: 5-Aminolevulinic Acid

Device: Orbeye surgical videomicroscope