Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas

• Sponsor: Northwell Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04937244
• Collaborator: Olympus Corporation (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Fluorescence-guided resection using 5-ALA induced tumor fluorescence of malignant gliomas allows for better identification of tumor tissue and more radical resection in select patients and improvements in progression-free and overall survival. With new developments in surgical microscopy, the development of digital exoscopes have provided advanced visualization as well as improvements in ergonomics and accessibility of the surgical field. The use of the exoscope in 5-ALA fluorescence-guided tumor surgery has the potential to enhance the ability of the surgeon to remove brain tumors with high efficacy. While algorithms for use of 5-ALA fluorescence have been optimized for use with traditional microscopes, the use of fluorescence techniques in newer digital exoscopes have not been developed. The primary outcome of the study is to obtain parameters to optimize visualization of fluorescence intensity and perform optimization based on the intensities achieved. The operating ORBEYE exoscope will be fitted with a blue light filter. All experiments will be performed in darkened operating rooms. The ORBEYE exoscope will be set up at constant distances from the target and incident light intensities. The focal distance and light intensity settings will be recorded from the data displayed on the microscope. Patients (experimental group) will receive 5ALA treatment before operation, blue light filter imagining will take place after tacking up dura and prior to direct resection. The expected outcomes of image analysis will be to have a set of exoscope parameters optimized for visualization of 5ALA tissue in different tumor types. This 5ALA characterization of visualization parameters has never been completed on an exoscope. Optimizing ORBEYE exoscope parameters will define a standard in glioma resection using 5ALA under a novel exoscopic filter as well as contribute insight into the use of the fluorescent filter for additional tumor types.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma of Brain	Diagnostic Test: 5ALA exoscopic fluorescence filter	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas
• Actual Study Start Date: May 13, 2021
• Anticipated Primary Completion Date: May 11, 2022
• Anticipated Study Completion Date: May 11, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Patients with new or recurrent malignant gliomas

Diagnostic Test: 5ALA exoscopic fluorescence filter; Visualization of tumor tissue with 5ALA will be done in the operating room to localize neoplastic tissue. The operation will be conducted in a standard fashion uninfluenced by the imaging on the ORBEYE exoscope. The ORBEYE exoscope will be used with the blue light filter after tacking up dura upon first visualization of tumor tissue prior to direct resection. Images will be taken prior to, during and at the end of the planned resection. The ORBEYE exoscope will be set up at constant distances from the target and incident light intensities. The focal distance and light intensity settings will be recorded from the data displayed on the microscope. The ORBEYE exoscope or standard operating microscope (depending on surgeon preference) will then be used in the standard fashion of an operative microscope with a fluorescent filter, to assist with surgical resection as per the surgeon's preference. Resection will proceed according to current standard of care.

Outcome Measures

Primary Outcome Measures

1. Focal Distance [6 weeks]

   To characterize optimal focal distance on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal

2. Light Intensity [6 weeks]

   To characterize optimal light intensity settings on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal

3. Working Angle [6 weeks]

   To characterize optimal working angle position on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal

Secondary Outcome Measures

1. Usability of 5ALA exoscope filter as assessed by overall surgery length [6 weeks]

   To determine functionality and performance reliability of the blue light excitation filter on the ORBEYE exoscope platform with overall surgery length

2. Usability of 5ALA exoscope filter as assessed by surgeon qualitative assessment [6 weeks]

   To determine functionality and performance reliability of the blue light excitation filter on the ORBEYE exoscope platform with surgeon qualitative assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female ≥ 18 years of age

• Must have a suspected or biopsy-proven 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%

• Willing and able to provide informed consent or have surrogate consent by legally authorized representative

Exclusion Criteria:

• Male and female < 18 years of age

• Porphyria, hypersensitivity to porphyrins

• Renal insufficiency as defined by a creatinine > 2.0 mg/dL

• Hepatic insufficiency as diagnosed in preoperative medical clearance evaluation

• Females of childbearing potential with a positive pregnancy test

• Nursing women

• Unwilling or unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lenox Hill Hospital	New York	New York	United States	10075

Sponsors and Collaborators

• Northwell Health
• Olympus Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Belykh E, Miller EJ, Patel AA, Bozkurt B, Yağmurlu K, Robinson TR, Nakaji P, Spetzler RF, Lawton MT, Nelson LY, Seibel EJ, Preul MC. Optical Characterization of Neurosurgical Operating Microscopes: Quantitative Fluorescence and Assessment of PpIX Photobleaching. Sci Rep. 2018 Aug 22;8(1):12543. doi: 10.1038/s41598-018-30247-6.
• Hadjipanayis CG, Widhalm G, Stummer W. What is the Surgical Benefit of Utilizing 5-Aminolevulinic Acid for Fluorescence-Guided Surgery of Malignant Gliomas? Neurosurgery. 2015 Nov;77(5):663-73. doi: 10.1227/NEU.0000000000000929. Review.
• Langer DJ, White TG, Schulder M, Boockvar JA, Labib M, Lawton MT. Advances in Intraoperative Optics: A Brief Review of Current Exoscope Platforms. Oper Neurosurg (Hagerstown). 2020 Jul 1;19(1):84-93. doi: 10.1093/ons/opz276. Review.

• Responsible Party: Northwell Health
• ClinicalTrials.gov Identifier: NCT04937244
• Other Study ID Numbers: 2021-SE-01
• First Posted: Jun 23, 2021
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Jun 23, 2021