Intraoperative Fluorescence With Augmented Reality

Study Overview
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Brief Summary
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This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard & approved intravenous dye and augmented reality.

Detailed Description
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This is a study investigating a new technique with an approved medication (ICG or indocyanine green) and using that and a near infrared mode on a standard operating room microscope to see the information provided for vascular or neoplastic (tumor related) neurosurgical problems. The technique uses the data from the microscope and using ICG with augmented reality overlaying the data into the microscope view (this is the new process). The technique is called GLOW800.

Official Title
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Phase 4 Open Label Study Of Indocyanine Green Video Angiography (ICG-VA) And Comparative Utility Of Glow800 And FL800 Intraoperative ICG-VA Tools For Intracranial Lesions

Conditions
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Vascular; Lesion, Central Nervous System, Brain Tumor, Cerebral Aneurysm, Cerebral AVM

Intervention / Treatment
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* Device: GLOW800
* Drug: indocyanine green (ICG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used Exclusion Criteria: allergy to ICG (indocyanine green)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery | Device: GLOW800<br>* The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery<br>Drug: indocyanine green (ICG)<br>* This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of Glow800 Technique | Surgeon assessment of Glow800 compared to ICG-VA in usefulness | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility in Identifying a lesion | Surgeon assessment of Glow800 vs ICG-VA in identifying vascular structures (useful, somewhat useful, not useful) | 48 hours | 
| Surgical workflow | Surgeon assessment of whether there is additional time (no additional time, <15 minutes additional time, <30 minutes additional time, >30 minutes additional time) | 48 hours | 
| Additional Cost | Surgeon assessment as to whether there is additional cost at surgery | 48 hours |