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

Stanford University

Status

Withdrawn

Conditions

Brain Tumor

Treatments

Device: CONVIVO Confocal Endomicroscopy System

Study type

Interventional

Funder types

Other

Identifiers

NCT05247749

BRN0044 (Other Identifier)

IRB-48092 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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