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

NCT04055688 | Completed FDA Device

• 1 other identifier: MCC-20014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Glioma

Keywords

Orbeye Surgical Microscope; fluorescence-guided surgery; 5-ALA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Volume of Residual tumor

  up to 48 hours after surgery

• Number of Patients experiencing Adverse Events

  Up to 16 days after surgery

Other Outcomes (1)

• Post Surgery Questionnaire

  Surgery day one

Study Arms (1)

Participants with known or suspected high grade gliomas

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

Interventions

Orbeye surgical videomicroscope DEVICE

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.

Participants with known or suspected high grade gliomas

5-Aminolevulinic Acid DRUG

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.

Also known as: 5-ALA

Participants with known or suspected high grade gliomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioma patients at Moffitt Cancer Center

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Olympus Corporation: collaborator

Study Sites (1)

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michael A Vogelbaum, MD, PhD

  H. Lee Moffitt Cancer and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: August 15, 2019
• Primary Completion: December 17, 2019
• Study Completion: February 23, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)