CONVIVO System for Brain Tumor Detection

Overseen By Linton T Evans, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Pregnancy, Children, FNa allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of the CONVIVO system, a special imaging tool, in distinguishing between healthy and abnormal brain tissue during surgery. The system examines brain tissue in real-time and compares these images to standard lab tests. The researchers aim to determine if the images from the CONVIVO system align with traditional lab results. This study may suit adults undergoing brain surgery for conditions such as gliomas, brain metastasis, or other types of brain tumors. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the CONVIVO system is safe for brain tumor detection?

Research shows that the CONVIVO System aids doctors during brain tumor surgery by clearly distinguishing between normal and abnormal tissue. Earlier studies proved it provides clear images of the brain during operations, facilitating quick decisions by surgeons.

The CONVIVO System has FDA approval, indicating it meets specific safety standards. Studies have found that patients generally tolerate the system well, with no major reports of harm from the device itself.

The procedure involves using a dye called fluorescein to highlight tissue. This dye, also used in other medical procedures, is usually safe. Some individuals might experience mild reactions, such as nausea or a rash, but these are uncommon.

Overall, the CONVIVO System appears safe for use during brain tumor surgeries. Discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONVIVO System for brain tumor detection because it offers a real-time imaging technique that could enhance precision during surgery. Unlike traditional methods that rely on post-operative histologic evaluation, the CONVIVO System uses in vivo imaging with a special dye called fluorescein, which is administered intravenously. This allows surgeons to visualize tumor margins more accurately during the operation, potentially leading to more effective tumor removal. This innovative approach could improve surgical outcomes by reducing the likelihood of leaving behind cancerous tissue and minimizing the need for additional surgeries.

What evidence suggests that the CONVIVO System is effective for brain tumor detection?

Research has shown that the CONVIVO System, one of the study arms in this trial, may help surgeons distinguish between healthy and abnormal brain tissue during surgery. Studies suggest that this system can be as effective as traditional methods, such as the conventional histologic evaluation arm, which involves examining tissue under a microscope, in identifying brain tumors. The CONVIVO System uses a special type of imaging to view tissues in real-time during surgery. This technology assists doctors in making more accurate decisions when removing brain tumors. Early findings indicate it could improve surgical results by providing detailed images quickly. ^{1 2 6 7 8}

Who Is on the Research Team?

Linton T Evans, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected brain tumors like gliomas, meningiomas, and pituitary adenomas who can undergo surgery. It's not for pregnant individuals, children under 18, or those allergic to Fluorescein sodium.

Inclusion Criteria

I am an adult who may have a brain tumor and can undergo surgery.

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

You are allergic to fluorescein sodium (FNa).

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

During tumor resection, the CONVIVO system is used for in vivo imaging following administration of fluorescein. Images are compared to conventional histologic specimens.

Day of surgery (Day 0)

1 visit (in-person)

Postoperative Monitoring

Postoperative MRI is obtained to assess the extent of tumor resection and monitor for adverse events related to fluorescein administration.

2 days after surgery up to one month

Follow-up

Participants are monitored for safety and effectiveness after treatment, including interpretation of imaging and histology.

Up to one month

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Histologic Evaluation
• CONVIVO System

Trial Overview The CONVIVO system is being tested against standard tissue evaluation during brain tumor surgery. The goal is to see if the CONVIVO's in-situ images match up well with traditional biopsy results.

How Is the Trial Designed?

Group I: Conventional histologic evaluation Experimental Treatment 1 Intervention

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.

Group II: CONVIVO system Experimental Treatment 1 Intervention

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.

CONVIVO System is already approved in United States for the following indications:

Approved in United States as CONVIVO System for:

• Intraoperative visualization of tissue microstructure during cranial procedures

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Carl Zeiss Meditec, Inc.

Industry Sponsor

Trials

24

Recruited

5,700+

Published Research Related to This Trial

Confocal laser endomicroscopy (CLE) is a promising non-invasive imaging technique that can enhance intraoperative tumor diagnosis and staging in neurosurgery, particularly for diffusely infiltrating gliomas.

CLE allows for near-real-time tumor analysis, which could significantly improve tumor resection strategies and may change the role of neuropathologists during surgeries, presenting both new opportunities and challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative confocal laser endomicroscopy for brain tumors - potential and challenges from a neuropathological perspective. Maragkou, T., Quint, K., Pollo, B., et al.[2023]

A handheld confocal endomicroscope successfully provided real-time histological information on gliomas and surrounding brain tissue in animal models, using various rapid-acting fluorophores to visualize tumor margins and normal brain structures.

The imaging technique revealed important features such as satellite tumor cells and definitive tumor borders, suggesting that intraoperative confocal imaging could enhance surgical decision-making during brain tumor resections, although further clinical trials are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential application of a handheld confocal endomicroscope imaging system using a variety of fluorophores in experimental gliomas and normal brain. Martirosyan, NL., Georges, J., Eschbacher, JM., et al.[2022]

Handheld confocal laser endomicroscopy (CLE) can effectively identify glioma margins in vivo using tumor-specific fluorescent labeling, as demonstrated in a study with 13 rats implanted with fluorescently labeled tumor cells.

The use of GFP and FITC-EGFR fluorescent labeling allowed for real-time imaging of tumor cells and their borders, correlating well with standard histological methods, suggesting that CLE could enhance surgical precision in brain tumor resections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handheld confocal laser endomicroscopic imaging utilizing tumor-specific fluorescent labeling to identify experimental glioma cells in vivo. Martirosyan, NL., Georges, J., Kalani, MY., et al.[2022]

The CONVIVO confocal endomiscroscope is being evaluated in a prospective study involving 75 patients, primarily those with high-grade gliomas, to assess its ability to provide accurate intraoperative histological diagnoses and identify tumor margins during brain surgery.

This study aims to establish the effectiveness of CONVIVO in real-time tumor assessment, potentially improving surgical decision-making and outcomes in neuro-oncological procedures, marking a significant advancement in the use of confocal laser technology in live surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new study protocol for in-vivo assessment of tumor diagnosis and microscopic tumor infiltration at the resection cavity in central nervous system tumors by a new miniature confocal endomicroscope (CONVIVO system). Restelli, F., Mazzapicchi, E., Pollo, B., et al.[2023]

Complete resection of brain tumors is crucial for improving postoperative survival, and while frozen section analysis is a common method for intraoperative diagnosis, it has limitations.

The ZEISS CONVIVO system, using sodium fluorescein, shows promise for providing near real-time histological images during neurosurgery, helping to accurately identify brain tumors and differentiate between healthy and diseased tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal laser imaging in neurosurgery: A comprehensive review of sodium fluorescein-based CONVIVO preclinical and clinical applications. Restelli, F., Mathis, AM., Höhne, J., et al.[2022]

The CONVIVO® system, a new miniature confocal laser endomicroscopy (CLE) device, demonstrated a high concordance rate with standard frozen section analyses for diagnosing glioblastoma during surgery, achieving 80% accuracy for diagnosis and 93.3% for categorizing tumor patterns at the central core.

The results suggest that CLE can serve as a valuable complementary tool for real-time intraoperative diagnosis, with quick interpretation times averaging around 5.74 minutes, enhancing the surgical decision-making process for glioblastoma removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex Vivo Fluorescein-Assisted Confocal Laser Endomicroscopy (CONVIVO® System) in Patients With Glioblastoma: Results From a Prospective Study. Acerbi, F., Pollo, B., De Laurentis, C., et al.[2022]

Confocal endomicroscopy is a high-resolution, non-invasive imaging technology that allows for real-time evaluation of cellular features in tissues, which is particularly useful for early detection of cancers in epithelial tissues.

Recent advancements have significantly improved the technology, achieving resolutions as fine as 0.5 μm and enabling the imaging of complex systems in the body, which may enhance diagnostic accuracy and guide biopsies more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confocal endomicroscopy: instrumentation and medical applications. Jabbour, JM., Saldua, MA., Bixler, JN., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05139277

NCT05139277 | Evaluation of the CONVIVO System The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12116572/

A single-institution experience with intraoperative in vivo ... We evaluated the feasibility and diagnostic capability of the first clinically approved CLE system for intraoperative in vivo imaging of brain tumors.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06087393

Study Details | NCT06087393 | CONVIVO Endomicroscopy The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05139277/evaluation-of-the-convivo-system

Evaluation of the CONVIVO System The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/312336

Evaluation of the CONVIVO System - Carebox Connect The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36112123/

A new study protocol for in-vivo assessment of tumor ... Main objectives will be the assessing of the concordance of tumor diagnoses between CONVIVO images and frozen section at the center of all tumor ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1565935/full

A single-institution experience with intraoperative in vivo ... We evaluated the feasibility and diagnostic capability of the first clinically approved CLE system for intraoperative in vivo imaging of brain tumors.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9574261/

Confocal laser imaging in neurosurgery - PubMed Central - NIH Confocal laser technology has been suggested as a promising method to have near real-time intraoperative histological images in neurosurgery.