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

Completed

• Conditions: Glioma; Brain Tumor
• Interventions: Device: Orbeye surgical videomicroscope; Drug: 5-Aminolevulinic Acid

• Registration Number: NCT04055688
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-08-15
• Primary Completion: 2019-12-17
• Study Completion: 2021-02-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with known or suspected high grade gliomas	Orbeye surgical videomicroscope	-
Participants with known or suspected high grade gliomas	5-Aminolevulinic Acid	-

Primary Outcome Measures

Name	Time	Method
Compare Visualized Fluroescence within brain tumors	Surgery day one	6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.

Secondary Outcome Measures

Name	Time	Method
Volume of Residual tumor	up to 48 hours after surgery	Residual tumor volume will be identified in post surgical MRI scans. Extent of resection will be compared to preoperative MRI scans.
Number of Patients experiencing Adverse Events	Up to 16 days after surgery	Patients will be assessed for neurological and general side effects/toxicities 7-16 days after surgery.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer and Research Institute; 🇺🇸 Tampa, Florida, United States