Brain TumorCONVIVONCT04280952
Confocal Laser Endomicroscopy for Brain Tumors
A study testing CONVIVO in people with Brain Tumor and Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Surgery, Convivo System
- What is being tested?
- CONVIVO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jun 2020to 30 Jun 2023
- 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 patient is undergoing neurosurgery for a suspected brain tumor and amenable to surgical resection by fluorescent guided technique
- The patient has an indication for tumor resection
- Macroscopic tumor visualization using sodium fluorescein is planned, concentration 5-10mg/kg
- The patient is older than 18 years
- Written consent
Who cannot join
- Stereotactic biopsy procedure
- Patients with any kind of contraindication to the use of fluorescein sodium
- Vulnerable persons (pregnant women, patients with Glasgow Coma Scale below 14)
- Participation in other ongoing clinical trials with one exception: double inclusions are allowed provided that no interaction with NaF is to be expected
- People who do not want to participate in the study
- Tumors that do not exactly match the inclusion criteria
- Emergency procedures in which no consent was obtained before the operation.
- Multiple surgeries on the same patient.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurosurgery, Bern University Hospital
Bern, 3010
About this study
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery will be demonstrated in this clinical trial.
Read the detailed description
Background:
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery still needs to be demonstrated
Methods:
Intravenous injection dose of fluorescein sodium. For every operation the investigators plan to take pictures with the CONVIVO system before taking the material for standard frozen section and definitive histopathology. These pictures will be evaluated by a pathologist afterwards.
Objectives:
The primary objective of this trial is to demonstrate, that the CONVIVO system allows identification of tumor tissue. The secondary objectives are procedural aspects and handling issues covering the usability.
- Conditions
- Brain Tumor, Surgery, Convivo System, Laser Endomicroscopy
- Being tested
- CONVIVO
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVIVODevice
tumor tissue with the CONVIVO system
| Study group | Role | What they receive |
|---|---|---|
| CONVIVO | Experimental | tumor tissue identification with the CONVIVO system Receives: Device: CONVIVO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of tumor tissue
Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section
Measured: End of surgery
Secondary outcomes (3)
Accuracy of CONVIVO results
Accuracy of CONVIVO results compared with results of final tumor histopathology
Measured: 14 days after surgery
Time for tissue visualization with the CONVIVO system
Intraoperative time for the tissue visualization with the CONVIVO system
Measured: End of surgery
Rate of unclear visualizations
Rate of unclear visualizations in %
Measured: 14 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 posted21 Feb 2020
- Study start5 Jun 2020
- Primary completion13 Jun 2023
- Study completion30 Jun 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tumor tissue identification with CONVIVO system
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Seidel, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280952
- Sponsor's protocol ID
- CONVIVO
- Acronym
- CONVIVO
- Status last verified
- Jul 2023
- First submitted
- 20 Feb 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy for Brain Tumors
- ClinicalTrials.gov ID
- NCT04280952
- Acronym / sponsor ID
- CONVIVO / CONVIVO
- Conditions
- Brain Tumor, Surgery, Convivo System, Laser Endomicroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Feb 2020 (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 prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery will be demonstrated in this clinical trial.
Detailed description
Background:
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery still needs to be demonstrated
Methods:
Intravenous injection dose of fluorescein sodium. For every operation the investigators plan to take pictures with the CONVIVO system before taking the material for standard frozen section and definitive histopathology. These pictures will be evaluated by a pathologist afterwards.
Objectives:
The primary objective of this trial is to demonstrate, that the CONVIVO system allows identification of tumor tissue. The secondary objectives are procedural aspects and handling issues covering the usability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tumor tissue identification with CONVIVO system
| Arm | Type | Receives |
|---|---|---|
| CONVIVO | Experimental | Device: CONVIVOtumor tissue identification with the CONVIVO system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is undergoing neurosurgery for a suspected brain tumor and amenable to surgical resection by fluorescent guided technique
- The patient has an indication for tumor resection
- Macroscopic tumor visualization using sodium fluorescein is planned, concentration 5-10mg/kg
- The patient is older than 18 years
- Written consent
Key exclusion criteria (8 listed)
- Stereotactic biopsy procedure
- Patients with any kind of contraindication to the use of fluorescein sodium
- Vulnerable persons (pregnant women, patients with Glasgow Coma Scale below 14)
- Participation in other ongoing clinical trials with one exception: double inclusions are allowed provided that no interaction with NaF is to be expected
- People who do not want to participate in the study
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 |
|---|---|---|
| CONVIVOtumor tissue with the CONVIVO system | Device | CONVIVO |
Primary outcome
Identification of tumor tissue
Time frame: End of surgery
Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section
3 secondary outcomes
Accuracy of CONVIVO results
Time frame: 14 days after surgery
Time for tissue visualization with the CONVIVO system
Time frame: End of surgery
Rate of unclear visualizations
Time frame: 14 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 5 Jul 2023.
- 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.
Kathleen Seidel, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONVIVO in people with Brain Tumor and Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 8 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 5 Jul 2023. 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 Switzerland. 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?
Identification of tumor tissue (time frame: End of surgery). 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 5 Jul 2023.