Status:
COMPLETED
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Olympus Corporation
Conditions:
Brain Tumor
Glioma
Eligibility:
All Genders
18+ years
Brief Summary
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 visua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04055688
Start Date
August 15 2019
End Date
February 23 2021
Last Update
May 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States, 33612