CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2022-05-31

Brief Summary

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The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

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Detailed Description

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Primary Objective:

The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.

Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging

-To describe the ability of the CONVIVO imaging system to generate readable images.

Conditions

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Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Convivo Imaging

The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device

Group Type EXPERIMENTAL

CONVIVO Confocal Endomicroscopy System

Intervention Type DEVICE

Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss

Interventions

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CONVIVO Confocal Endomicroscopy System

Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
* The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
* The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
* Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
* The subject is older than 18 years.
* The subject is receiving their surgery at Stanford Hospital.