30 Participants NeededMy employer runs this trial

CONVIVO Endomicroscopy for Brain Tumor

BM
Overseen ByBetsy Moclair
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well the CONVIVO Endomicroscopy tool assists surgeons in viewing brain tissue details during surgery. By using this technology, doctors can better distinguish between healthy and abnormal brain tissues in real-time, potentially improving the accuracy of brain tumor surgeries. It targets patients needing surgery for brain tumors, particularly those with high-grade, invasive types. This trial may suit individuals with an intracranial lesion requiring surgery who have not experienced allergic reactions to fluorescein or have asthma. As an unphased trial, it offers patients the opportunity to contribute to innovative research that may enhance surgical outcomes.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the CONVIVO Endomicroscopy is safe for use during neurosurgery?

Research has shown that the CONVIVO Endomicroscopy system is safe for use during brain surgery. Studies demonstrate that this technology provides real-time images of brain tissue without causing harm. In one study, the system successfully captured digital images without any reported negative side effects. Another study confirmed that the system is both safe and easy to use during surgery. The CONVIVO system is FDA-cleared, indicating it has passed safety checks for specific uses. It aids surgeons in distinguishing between healthy and tumor tissues in the brain. Overall, evidence supports its safety for patients undergoing brain tumor surgeries.12345

Why are researchers excited about this trial?

CONVIVO Endomicroscopy is unique because it offers a real-time, high-resolution view of brain tissue during surgery. Unlike traditional imaging methods, which can be time-consuming and less precise, this technique allows surgeons to make quicker and more accurate decisions about tumor boundaries. Researchers are excited about this technology because it has the potential to improve the precision of brain tumor surgeries, potentially leading to better outcomes and fewer complications for patients.

What evidence suggests that the CONVIVO Endomicroscopy is effective for brain tumors?

Research has shown that the CONVIVO Endomicroscopy system holds promise for brain tumor surgery. In earlier studies, this technology identified tumor edges with about 85.8% accuracy, a sensitivity of 89.6%, and a specificity of 79.4%. Another study found that integrating an AI model with this system increased the accuracy rate to 94% in detecting tumors. The system also provides real-time images, enabling doctors to differentiate between healthy and abnormal brain tissues during surgery. This capability can improve surgical outcomes by reducing the time required for traditional tissue analysis.12467

Are You a Good Fit for This Trial?

This trial is for adults needing brain surgery for suspected high-grade tumors or other brain pathologies. Participants must be able to give informed consent. It's not suitable for those with allergies to fluorescein, asthma, kidney failure, or for children under 18, pregnant or breastfeeding women.

Inclusion Criteria

All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use
I need surgery for a brain lesion.
I am having surgery to remove a brain tumor.
See 1 more

Exclusion Criteria

You have had a bad reaction to fluorescein in the past.
You have a history of allergies or asthma.
Pregnant women
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Intraoperative imaging of tissue microstructure and microvasculature using CONVIVO during neurosurgery

During surgery
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CONVIVO Endomicroscopy

Trial Overview

The CONVIVO system is being tested on patients during neurosurgery to see if it can help distinguish between healthy and abnormal brain tissue in real-time using a handheld device that provides digital images at a cellular level.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Citations

Clinical application of confocal laser endomicroscopy in ...

At the margins, CLE achieved an overall accuracy of 85.8% (sensitivity 89.6%, specificity 79.4%) across all tumors, and 82.2% accuracy in glioblastoma/grade 4 ...

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.

AI Augmented Confocal Laser Endomicroscopy for Rapid ...

The AI model showed diagnostic accuracies of 0.94 for tumor detection and 0.88 for biopsy subtype diagnosis. Overall, CLE demonstrated ...

Ex Vivo Fluorescein-Assisted Confocal Laser ...

Comparing CONVIVO® and permanent sections, concordance resulted similar at central core (total/partial concordance in 80 and 86.7% for diagnosis ...

prospective in vivo feasibility study of a clinical-grade system ...

Intraoperative confocal laser endomicroscopy: prospective in vivo feasibility study of a clinical-grade system for brain tumors. Irakliy Abramov.

A prospective multicenter assessor blinded pilot study ...

cCeLL-Ex vivo exhibited a relatively higher diagnostic accuracy (89.2%) than frozen section analysis (86.5%), with both methods showing a sensitivity of 92.2%.

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 ...