GlioblastomaNCT05139277
Evaluation of the CONVIVO System
A study testing CONVIVO system and Conventional histologic evaluation in people with Glioblastoma and Glial Tumor, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glial Tumor, Brain Metastases
- What is being tested?
- CONVIVO system and Conventional histologic evaluation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients (age>18)
- Adults presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates
- Adults able to provide informed consent.
Who cannot join
- Pregnancy
- Children (age <18 years)
- Fluorescein sodium (FNa) allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Linton T Evans, MD, 603-650-5026, linton.t.evans@hitchcock.org
Linton T Evans, MD
About this study
Official title: Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection
The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.
Read the detailed description
The surgical resection of brain tumors is an integral component of modern neuro-oncology. . Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Unfortunately, there are a number of obstacles unique to brain tumors that may limit the extent of resection. A number of advancements in neurosurgical oncology have emerged to improve the extent of tumor resection while decreasing operative morbidity and mortality. Confocal reflectance microscopy is a routine technique used to visualize tissues without fixation or staining used in classical histological techniques. Laser scanning confocal microscopy (LSCM) is an optical fluorescence imaging modality used for imaging thick in vivo and ex vivo tissues. Clinically available confocal endomicroscopy systems contain lasers with precise excitation wavelengths and dichroic filters for detecting appropriate emission wave lengths. The studies completed to date do not evaluate the ability of confocal microscopy to discriminate between normal and abnormal tissue at the margins during surgical resection. This is the first of such in vivo feasibility studies that aims to demonstrate this claim of the CONVIVO system.
The images acquired with the CONVIVO system following administration of fluorescein will be compared to conventional histologic specimens from corresponding biopsies. This is a planned single center study. This study is designed to assess the diagnostic accuracy of the CONVIVO system compared with gold-standard histopathology in tissue that has already been identified for resection. The device will not be used to inform surgical decision making, nor will tissue that would not otherwise be resected be biopsied for research purposes.
This study will rely on study investigators, all physicians at Dartmouth-Hitchcock, to identify subjects. Written consent is required for participation in the study.. There are no specific medical risks to patients associated with the use of CONVIVO. It is not anticipated that there are immediate or direct benefits to patients participating in this study. The CONVIVO imaging data acquired during the procedure will be initially stored on the device's hard drive and later securely uploaded to an encrypted Dartmouth-Hitchcock server. Patients will have the ability to maintain their privacy with minimal disruption or contact by the study team. Additionally, the PI or other investigators will have interactions with the patient as part of their routine clinical care. Participants are free to withdraw from participation in the study at any time upon request.
- Conditions
- Glioblastoma, Glial Tumor, Brain Metastases, Meningioma, Schwannoma, Pituitary Tumor
- Being tested
- CONVIVO system, Conventional histologic evaluation
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms, Meningioma, Neurilemmoma, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVIVO systemDiagnostic test
Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Again this will only be in regions that would normally be resected or sampled in routine clinical care. Following image acquisition, a neuropathologist present in the operating room, will review and capture each image.
Conventional histologic evaluationOther
Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.
| Study group | Role | What they receive |
|---|---|---|
| CONVIVO system | Experimental | During tumor resection, study investigators trained in the use of the system will determine when the CONVIVO imaging system will be used for in vivo¬ imaging. At this point 5 mg/kg of fluorescein will be administered intravenously by an anesthesia provider over one minute.Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Receives: Diagnostic Test: CONVIVO system |
| Conventional histologic evaluation | Other | Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample. Receives: Other: Conventional histologic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue
Concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment.The diagnostic performance of the CONVIVO system will be assessed with respect to classification as "normal" or "abnormal" tissue. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. Pertinent tumors include all intracranial neoplasms including low and high grade glial neoplasms, glioneuronal tumors, cerebral metastasis, meningioma, schwannoma, and pituitary lesions.
Measured: On day of Surgery, Day 0
Secondary outcomes (10)
Degree of concordance with histologic diagnosis
Degree of concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment or frozen with respect to histologic diagnosis.
Measured: On day of surgery, Day 0
Sensitivity and Specificity of CONVIVO system
Sensitivity and specificity analysis of CONVIVO using area under the curve and receiver operating characteristics. Conventional histopathology will be the gold-standard.
Measured: On day of surgery, Day 0
Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system.
Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system. During the resection the PI or other investigators may image tissue that is ultimately not biopsied. For example at the end of resection if there is a region of interest that cannot be safely resected, the CONVIVO system can be used to image the tissue without obtaining a corresponding tissue specimen for histology. During image acquisition it will be noted and documented by the research team that there is not a corresponding tissue specimen.
Measured: On day of surgery, Day 0
Correlation between intra-operative confocal microscopy and co-registered MRI points.
MRI characteristics will include (i) the presence or absence of contrast enhancement; (ii) signal intensity on T2 weighted images; (iii) perfusion based and spectroscopy imaging; (iv) diffusion weighted sequences.
Measured: On day of surgery, Day 0
Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy.
Following image coregistration, the 560 yellow light filter on the Kinevo microscope will be used to determine the visible fluorescence in the region that was interrogated and classified from 0 to 4 based upon the fluorescence intensity. This will be recorded by the research team. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2-moderate intensity, 3-strong intensity.
Measured: On day of surgery, Day 0
Correlation between visible blue-light fluorescence and quantitative fluorescence measurements
If the participant has also received 5-ALA, the 400 nm blue light filter will then be selected and the visible fluorescence of PPIX will also be classified from 0 to 4 based upon the fluorescence intensity. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2- moderate intensity, 3-strong intensity.
Measured: On day of surgery, Day 0
Extent of tumor resection
Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Postoperative MRI is obtained as appropriate, as it relates to extent of resection.
Measured: 2 Days after surgery up to one month.
Adverse events related to the administration of fluorescein
Record adverse events as reported by participant or observed by investigator related to the administration of fluorescein
Measured: Day of surgery (Day 0), 2 Days after surgery up to one month.
Time to interpretation of imaging and histology
Time to pathologic interpretation of intraoperative imaging compared to conventional interpretation of histology.Currently, the frozen section provides intraoperative histopathological analysis of brain tumors. Though useful, this process is time consuming and requires the cutting, freezing, and staining of several biopsies.
Measured: Day of surgery (Day 0), and up to one week
Ability to discriminate between viable tumor and pseudoprogression or "treatment effect" using the CONVIVO system.
The WHO criteria for the diagnosis of Glioblastoma (GBM) - cell density, cellular pleomorphism, increased mitoses, microvascular proliferation and trpalisading or ischemic necrosis - were all detectable by Confocal EndoMicroscope (CEM). Identification of the infiltration zone or the center of the tumor was possible based upon assessments of cell density comparing the center and border specimens. Additional aspects, e.g. apoptotic figures in perinecrotic pseudopalisading tumor cells, and important histological structures such as giant cells, fibrillary tumor matrix and blood vessels were also visible with CEM. Typical features of CEM in patients with histologically proven meningioma were also seen.
Measured: Day of surgery (Day 0) and up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start28 Jun 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Adult patients (age\>18) presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates and provide informed consent.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Principal investigator, Linton T. Evans, Dartmouth-Hitchcock Medical Center
- Investigators
- Linton T Evans, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139277
- Sponsor's protocol ID
- D20056
- Other IDs
- NCI-2023-06342
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans at this time to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. 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 From Abnormal Tissue During Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT05139277
- Acronym / sponsor ID
- D20056
- Conditions
- Glioblastoma, Glial Tumor, Brain Metastases, Meningioma, Schwannoma, Pituitary Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Dec 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.
The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.
Detailed description
The surgical resection of brain tumors is an integral component of modern neuro-oncology. . Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Unfortunately, there are a number of obstacles unique to brain tumors that may limit the extent of resection. A number of advancements in neurosurgical oncology have emerged to improve the extent of tumor resection while decreasing operative morbidity and mortality. Confocal reflectance microscopy is a routine technique used to visualize tissues without fixation or staining used in classical histological techniques. Laser scanning confocal microscopy (LSCM) is an optical fluorescence imaging modality used for imaging thick in vivo and ex vivo tissues. Clinically available confocal endomicroscopy systems contain lasers with precise excitation wavelengths and dichroic filters for detecting appropriate emission wave lengths. The studies completed to date do not evaluate the ability of confocal microscopy to discriminate between normal and abnormal tissue at the margins during surgical resection. This is the first of such in vivo feasibility studies that aims to demonstrate this claim of the CONVIVO system.
The images acquired with the CONVIVO system following administration of fluorescein will be compared to conventional histologic specimens from corresponding biopsies. This is a planned single center study. This study is designed to assess the diagnostic accuracy of the CONVIVO system compared with gold-standard histopathology in tissue that has already been identified for resection. The device will not be used to inform surgical decision making, nor will tissue that would not otherwise be resected be biopsied for research purposes.
This study will rely on study investigators, all physicians at Dartmouth-Hitchcock, to identify subjects. Written consent is required for participation in the study.. There are no specific medical risks to patients associated with the use of CONVIVO. It is not anticipated that there are immediate or direct benefits to patients participating in this study. The CONVIVO imaging data acquired during the procedure will be initially stored on the device's hard drive and later securely uploaded to an encrypted Dartmouth-Hitchcock server. Patients will have the ability to maintain their privacy with minimal disruption or contact by the study team. Additionally, the PI or other investigators will have interactions with the patient as part of their routine clinical care. Participants are free to withdraw from participation in the study at any time upon request.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult patients (age>18) presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates and provide informed consent.
| Arm | Type | Receives |
|---|---|---|
| CONVIVO system | Experimental | Diagnostic Test: CONVIVO systemDuring tumor resection, study investigators trained in the use of the system will determine when the CONVIVO imaging system will be used for in vivo¬ imaging. At this point 5 mg/kg of fluorescein will be administered intravenously by an anesthesia provider over one minute.Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. |
| Conventional histologic evaluation | Other | Other: Conventional histologic evaluationFollowing image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age>18)
- Adults presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates
- Adults able to provide informed consent.
Key exclusion criteria (3 listed)
- Pregnancy
- Children (age <18 years)
- Fluorescein sodium (FNa) allergy
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 systemApproximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Again this will only be in regions that would normally be resected or sampled in routine clinical care. Following image acquisition, a neuropathologist present in the operating room, will review and capture each image. | Diagnostic test | CONVIVO system |
| Conventional histologic evaluationFollowing image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample. | Other | Conventional histologic evaluation |
Primary outcome
Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue
Time frame: On day of Surgery, Day 0
Concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment.The diagnostic performance of the CONVIVO system will be assessed with respect to classification as "normal" or "abnormal" tissue. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. Pertinent tumors include all intracranial neoplasms including low and high grade glial neoplasms, glioneuronal tumors, cerebral metastasis, meningioma, schwannoma, and pituitary lesions.
10 secondary outcomes
Degree of concordance with histologic diagnosis
Time frame: On day of surgery, Day 0
Sensitivity and Specificity of CONVIVO system
Time frame: On day of surgery, Day 0
Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system.
Time frame: On day of surgery, Day 0
Correlation between intra-operative confocal microscopy and co-registered MRI points.
Time frame: On day of surgery, Day 0
Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy.
Time frame: On day of surgery, Day 0
Correlation between visible blue-light fluorescence and quantitative fluorescence measurements
Time frame: On day of surgery, Day 0
Extent of tumor resection
Time frame: 2 Days after surgery up to one month.
Adverse events related to the administration of fluorescein
Time frame: Day of surgery (Day 0), 2 Days after surgery up to one month.
Time to interpretation of imaging and histology
Time frame: Day of surgery (Day 0), and up to one week
Ability to discriminate between viable tumor and pseudoprogression or "treatment effect" using the CONVIVO system.
Time frame: Day of surgery (Day 0) and up to one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. There are no plans at this time to share IPD.
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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.
Linton T Evans, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 system and Conventional histologic evaluation in people with Glioblastoma and Glial Tumor, run by Dartmouth-Hitchcock Medical Center 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 3 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linton T Evans, MD (603-650-5026, Linton.T.Evans@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue (time frame: On day of Surgery, Day 0). 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 6 Feb 2026.