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

Sponsor

Stanford University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05247749

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor	Device: CONVIVO Confocal Endomicroscopy System	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Convivo Imaging The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device	Device: CONVIVO Confocal Endomicroscopy System Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss

Arm

Intervention/Treatment

Experimental: Convivo Imaging

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

Device: CONVIVO Confocal Endomicroscopy System

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Exclusion Criteria:

Patients with any kind of contraindication to the use of fluorescein

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Gordon Li, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT05247749

Other Study ID Numbers:

IRB-48092
BRN0044
IRB-48092

First Posted:

Feb 21, 2022

Last Update Posted:

Feb 21, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Feb 21, 2022