Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Stanford University
- Primary Endpoint
- Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
Time Frame: 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 Outcomes
- Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning(12 months)
- Ability of the CONVIVO system capture a readable image(12 months)