Brain TumorNCT04055688
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
An observational study of Brain Tumor and Glioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioma
- What is being tested?
- Orbeye surgical videomicroscope and 5-Aminolevulinic Acid
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 23 Feb 2021
- Phase
- Observational
- 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
Study population: Glioma patients at Moffitt Cancer Center
Who may be able to join
- Must have a suspected or biopsy-proven high-grade 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%
Who cannot join
- Prophyria, hypersensitivity to porphyrins
- Renal insufficiency as defined per protocol
- Hepatic insufficiency as defined per protocol
- Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
- Nursing women or women using inadequate contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, 33612
About this study
Official title: Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.
This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
- Conditions
- Brain Tumor, Glioma
- Being tested
- Orbeye surgical videomicroscope, 5-Aminolevulinic Acid
- Keywords
- Orbeye Surgical Microscope, fluorescence-guided surgery, 5-ALA
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbeye surgical videomicroscopeDevice
The ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation.
5-Aminolevulinic AcidDrug
Also called 5-ALA
5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes.
| Study group | Role | What they receive |
|---|---|---|
| Participants with known or suspected high grade gliomas | Not described Receives: Device: Orbeye surgical videomicroscope; Drug: 5-Aminolevulinic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Visualized Fluroescence within brain tumors
6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.
Measured: Surgery day one
Secondary outcomes (2)
Volume of Residual tumor
Residual tumor volume will be identified in post surgical MRI scans. Extent of resection will be compared to preoperative MRI scans.
Measured: up to 48 hours after surgery
Number of Patients experiencing Adverse Events
Patients will be assessed for neurological and general side effects/toxicities 7-16 days after surgery.
Measured: Up to 16 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start15 Aug 2019
- Primary completion17 Dec 2019
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation
- Responsible party
- Sponsor
- Investigators
- Michael A Vogelbaum, MD, PhD, Principal investigator, H. Lee Moffitt Cancer and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055688
- Sponsor's protocol ID
- MCC-20014
- Status last verified
- May 2022
- First submitted
- 12 Aug 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
- ClinicalTrials.gov ID
- NCT04055688
- Acronym / sponsor ID
- MCC-20014
- Conditions
- Brain Tumor, Glioma
- Keywords
- Orbeye Surgical Microscope, fluorescence-guided surgery, 5-ALA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Olympus Corporation
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 14 Aug 2019 (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.
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.
This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with known or suspected high grade gliomas | – | Device: Orbeye surgical videomicroscope, Drug: 5-Aminolevulinic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glioma patients at Moffitt Cancer Center
Key inclusion criteria (3 listed)
- Must have a suspected or biopsy-proven high-grade 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%
Key exclusion criteria (5 listed)
- Prophyria, hypersensitivity to porphyrins
- Renal insufficiency as defined per protocol
- Hepatic insufficiency as defined per protocol
- Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
- Nursing women or women using inadequate contraception
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 |
|---|---|---|
| Orbeye surgical videomicroscopeThe ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation. | Device | Participants with known or suspected high grade gliomas |
| 5-Aminolevulinic AcidAlso: 5-ALA5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes. | Drug | Participants with known or suspected high grade gliomas |
Primary outcome
Compare Visualized Fluroescence within brain tumors
Time frame: Surgery day one
6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.
2 secondary outcomes
Volume of Residual tumor
Time frame: up to 48 hours after surgery
Number of Patients experiencing Adverse Events
Time frame: Up to 16 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Michael A Vogelbaum, MD, PhD principal investigator
H. Lee Moffitt Cancer and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Glioma, run by H. Lee Moffitt Cancer Center and Research Institute 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 May 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Visualized Fluroescence within brain tumors (time frame: Surgery day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022.