Malignant Glioma of BrainPhase 4NCT04937244
Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas
A Phase 4 study testing 5ALA exoscopic fluorescence filter in people with Malignant Glioma of Brain, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma of Brain
- What is being tested?
- 5ALA exoscopic fluorescence filter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 11 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Randy D'Amico, 347-563-6587, rdamico8@northwell.edu
Randy D'Amico, MD
About this study
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.
- Conditions
- Malignant Glioma of Brain
- Being tested
- 5ALA exoscopic fluorescence filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5ALA exoscopic fluorescence filterDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with new or recurrent malignant gliomas | Experimental | Not described Receives: Diagnostic Test: 5ALA exoscopic fluorescence filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focal Distance
To characterize optimal focal distance on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
Measured: 6 weeks
Light Intensity
To characterize optimal light intensity settings on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
Measured: 6 weeks
Working Angle
To characterize optimal working angle position on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
Measured: 6 weeks
Secondary outcomes (2)
Usability of 5ALA exoscope filter as assessed by overall surgery length
To determine functionality and performance reliability of the blue light excitation filter on the ORBEYE exoscope platform with overall surgery length
Measured: 6 weeks
Usability of 5ALA exoscope filter as assessed by surgeon qualitative assessment
To determine functionality and performance reliability of the blue light excitation filter on the ORBEYE exoscope platform with surgeon qualitative assessment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start13 May 2021
- Primary completion11 May 2022 (estimated)
- Study completion11 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937244
- Sponsor's protocol ID
- 2021-SE-01
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Belykh E, Miller EJ, Patel AA, Bozkurt B, Yagmurlu 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.
PubMed 30135440Langer DJ, White TG, Schulder M, Boockvar JA, Labib M, Lawton MT. Advances in Intraoperative Optics: A Brief Review of Current Exoscope Platforms. Oper Neurosurg. 2020 Jul 1;19(1):84-93. doi: 10.1093/ons/opz276.
PubMed 31529083Hadjipanayis 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.
PubMed 26308630
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas
- ClinicalTrials.gov ID
- NCT04937244
- Acronym / sponsor ID
- 2021-SE-01
- Conditions
- Malignant Glioma of Brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Olympus Corporation
- Study start
- 13 May 2021 (actual)
- Primary completion
- 11 May 2022 (estimated)
- Study completion
- 11 May 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with new or recurrent malignant gliomas | Experimental | Diagnostic Test: 5ALA exoscopic fluorescence filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5ALA exoscopic fluorescence filterVisualization 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. | Diagnostic test | Patients with new or recurrent malignant gliomas |
Primary outcome
Focal Distance
Time frame: 6 weeks
To characterize optimal focal distance on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
Light Intensity
Time frame: 6 weeks
To characterize optimal light intensity settings on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
Working Angle
Time frame: 6 weeks
To characterize optimal working angle position on the 5ALA fluorescence ORBEYE exoscope microscope during glioma removal
2 secondary outcomes
Usability of 5ALA exoscope filter as assessed by overall surgery length
Time frame: 6 weeks
Usability of 5ALA exoscope filter as assessed by surgeon qualitative assessment
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Background: PubMed 30135440Belykh E, Miller EJ, Patel AA, Bozkurt B, Yagmurlu 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.
- Background: PubMed 31529083Langer DJ, White TG, Schulder M, Boockvar JA, Labib M, Lawton MT. Advances in Intraoperative Optics: A Brief Review of Current Exoscope Platforms. Oper Neurosurg. 2020 Jul 1;19(1):84-93. doi: 10.1093/ons/opz276.
- Background: PubMed 26308630Hadjipanayis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5ALA exoscopic fluorescence filter in people with Malignant Glioma of Brain, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focal Distance (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937244, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.