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

Not Applicable

Withdrawn

• Conditions: Brain Tumor
• Interventions: Device: CONVIVO Confocal Endomicroscopy System

• Registration Number: NCT05247749
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2021-05
• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

* Patients with any kind of contraindication to the use of fluorescein

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convivo Imaging	CONVIVO Confocal Endomicroscopy System	The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device

Primary Outcome Measures

Name	Time	Method
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon	12 months	Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion.

Secondary Outcome Measures

Name	Time	Method
Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning	12 months	Time for tissue visualization with CONVIVO system: defined as the total number of minutes from start of imaging device use to mock diagnosis. This is calculated by summing the number of minutes from the start of imaging device use to the end of imaging device use in the operating room and the number of minutes from the neuropathologist's start of image review to arrival at a mock diagnosis.; Time for standard cryosectioning: defined as the total number of minutes required for standard cryosectioning. This is calculated by summing the number of minutes from when the operating surgeon contacts the neuropathology department to request a frozen section analysis of tissue and ends when the neuropathology department calls the operating room with a suspected diagnosis, as measured by study personnel present in the operating room during the surgery
Ability of the CONVIVO system capture a readable image	12 months	A readable image is defined as an image from which a neuropathologist can make a mock diagnosis. This will be reported as a number without dispersion.