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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the CONVIVO System for brain tumor detection?

Research shows that the CONVIVO System, a type of confocal laser endomicroscopy, can provide near real-time, high-resolution images of brain tissue during surgery. This helps doctors identify and diagnose brain tumors more accurately and quickly, potentially improving surgical outcomes. ^{1 2 3 4 5}

Is the CONVIVO System safe for use in humans?

The CONVIVO System, a type of confocal endomicroscope, has been used in studies for brain tumor surgeries and is considered promising for providing real-time images during operations. While specific safety data is not detailed, the technology is non-invasive and has been used in clinical settings, suggesting it is generally safe for human use. ^{1 2 3 6 7}

How is the CONVIVO System treatment different from other brain tumor treatments?

The CONVIVO System is unique because it uses confocal laser endomicroscopy to provide near real-time, high-resolution images of brain tissue during surgery, helping surgeons identify tumor margins more accurately. This technology allows for immediate intraoperative diagnosis, which is not possible with traditional methods that rely on slower histopathological analysis. ^{1 2 3 5 6}

Research Team

Linton T Evans, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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 an adult who can understand and agree to the study's details.

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

You are allergic to fluorescein sodium (FNa).

Pregnancy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Italy 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). [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ex Vivo Fluorescein-Assisted Confocal Laser Endomicroscopy (CONVIVO® System) in Patients With Glioblastoma: Results From a Prospective Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Confocal endomicroscopy: instrumentation and medical applications. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Intraoperative confocal laser endomicroscopy for brain tumors - potential and challenges from a neuropathological perspective. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Handheld confocal laser endomicroscopic imaging utilizing tumor-specific fluorescent labeling to identify experimental glioma cells in vivo. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Confocal laser imaging in neurosurgery: A comprehensive review of sodium fluorescein-based CONVIVO preclinical and clinical applications. [2022]

7. United States 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. [2022]