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.

Study Overview

• Status: Completed
• Conditions: Glioma; Brain Tumor
• Intervention / Treatment: Device: Orbeye surgical videomicroscope; Drug: 5-Aminolevulinic Acid

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Glioma patients at Moffitt Cancer Center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with known or suspected high grade gliomas

Device: Orbeye surgical videomicroscope; The ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation.; Drug: 5-Aminolevulinic Acid; 5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes.; Other Names: 5-ALA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Visualized Fluroescence within brain tumors	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.	Surgery day one

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Surgery Questionnaire	Surgeons will complete a questionnaire after each surgery to assess the visual experience of using the ORBEYE during the surgical procedure. The questionnaire asks about the superiority of the ORBEYE system compared to conventional binocular microscope, using a scale of 1-5, 1 being strongly agree and 5 being strongly disagree.	Surgery day one

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Olympus Corporation
• Investigators: Principal Investigator: Michael A Vogelbaum, MD, PhD, H. Lee Moffitt Cancer and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: 5-ALA; Orbeye Surgical Microscope; fluorescence-guided surgery
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: MCC-20014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No