Brain TumorNCT05247749
CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection
A study testing CONVIVO Confocal Endomicroscopy System in people with Brain Tumor, run by Stanford University.
Trial summary
The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- CONVIVO Confocal Endomicroscopy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2022
- Phase
- Interventional
- 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
- The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
- The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
- The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
- Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
- The subject is older than 18 years.
- The subject is receiving their surgery at Stanford Hospital.
Who cannot join
- Patients with any kind of contraindication to the use of fluorescein
About this study
Official title: Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.
Read the detailed description
Primary Objective:
The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.
Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging
-To describe the ability of the CONVIVO imaging system to generate readable images.
- Conditions
- Brain Tumor
- Being tested
- CONVIVO Confocal Endomicroscopy System
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVIVO Confocal Endomicroscopy SystemDevice
Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss
| Study group | Role | What they receive |
|---|---|---|
| Convivo Imaging | Experimental | The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device Receives: Device: CONVIVO Confocal Endomicroscopy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion.
Measured: 12 months
Secondary outcomes (2)
Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
Time for tissue visualization with CONVIVO system: defined as the total number of minutes from start of imaging device use to mock diagnosis. This is calculated by summing the number of minutes from the start of imaging device use to the end of imaging device use in the operating room and the number of minutes from the neuropathologist's start of image review to arrival at a mock diagnosis.
Time for standard cryosectioning: defined as the total number of minutes required for standard cryosectioning. This is calculated by summing the number of minutes from when the operating surgeon contacts the neuropathology department to request a frozen section analysis of tissue and ends when the neuropathology department calls the operating room with a suspected diagnosis, as measured by study personnel present in the operating room during the surgery
Measured: 12 months
Ability of the CONVIVO system capture a readable image
A readable image is defined as an image from which a neuropathologist can make a mock diagnosis. This will be reported as a number without dispersion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Regulatory
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.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Li, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247749
- Sponsor's protocol ID
- IRB-48092
- Other IDs
- BRN0044, IRB-48092
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT05247749
- Acronym / sponsor ID
- IRB-48092
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Feb 2022 (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.
The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.
Detailed description
Primary Objective:
The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.
Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging
-To describe the ability of the CONVIVO imaging system to generate readable images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convivo Imaging | Experimental | Device: CONVIVO Confocal Endomicroscopy SystemThe brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
- The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
- The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
- Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
- The subject is older than 18 years.
Key exclusion criteria (1 listed)
- Patients with any kind of contraindication to the use of fluorescein
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 |
|---|---|---|
| CONVIVO Confocal Endomicroscopy SystemConfocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss | Device | Convivo Imaging |
Primary outcome
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
Time frame: 12 months
Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion.
2 secondary outcomes
Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
Time frame: 12 months
Ability of the CONVIVO system capture a readable image
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- 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.
Gordon Li principal investigator
Stanford Universiy
Questions about this trial
What is this clinical trial studying?
A study testing CONVIVO Confocal Endomicroscopy System in people with Brain Tumor, run by Stanford University.
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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon (time frame: 12 months). 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 21 Feb 2022.