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

PHASE4UnknownINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 13, 2021

Primary Completion Date

May 11, 2022

Study Completion Date

May 11, 2022

Conditions
Malignant Glioma of Brain
Interventions
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.

Trial Locations (1)

10075

RECRUITING

Lenox Hill Hospital, New York

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Olympus Corporation

INDUSTRY

lead

Northwell Health

OTHER

NCT04937244 - Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas | Biotech Hunter | Biotech Hunter