Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas
Public ClinicalTrials.gov record NCT04937244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04937244
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 12, 2021
- Primary completion
- May 10, 2022
- Completion
- May 10, 2022
- Last update posted
- Jun 22, 2021
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lenox Hill Hospital | New York | New York | 10075 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04937244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04937244 live on ClinicalTrials.gov.