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

NCT05247749 | Withdrawn DMC FDA Device

• 2 other identifiers: IRB-48092BRN0044
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon

  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.

  12 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Convivo Imaging

EXPERIMENTAL

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

Device: CONVIVO Confocal Endomicroscopy System

Interventions

CONVIVO Confocal Endomicroscopy System DEVICE

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

Convivo Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gordon Li

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share