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

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ClinicalTrials.gov Identifier: NCT04937244
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
Olympus Corporation
Information provided by (Responsible Party):
Northwell Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 11, 2022
Estimated Study Completion Date : May 11, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Focal Distance [ Time Frame: 6 weeks ]
    To characterize optimal focal distance on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal

  2. Light Intensity [ Time Frame: 6 weeks ]
    To characterize optimal light intensity settings on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal

  3. Working Angle [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks ]
    To determine functionality and performance reliability of the blue light excitation filter on the ORBEYE exoscope platform with surgeon qualitative assessment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937244


Locations
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United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Randy D'Amico    347-563-6587    rdamico8@northwell.edu   
Principal Investigator: Randy D'Amico, MD         
Sub-Investigator: John Boockvar, MD         
Sponsors and Collaborators
Northwell Health
Olympus Corporation
Publications:
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04937244    
Other Study ID Numbers: 2021-SE-01
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue