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

Primary Purpose

Brain Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CONVIVO Confocal Endomicroscopy System
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Convivo Imaging

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
    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
    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.

    Full Information

    First Posted
    February 9, 2022
    Last Updated
    February 18, 2022
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05247749
    Brief Title
    CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection
    Official Title
    Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Regulatory
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Tumor

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Convivo Imaging
    Arm Type
    Experimental
    Arm Description
    The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device
    Intervention Type
    Device
    Intervention Name(s)
    CONVIVO Confocal Endomicroscopy System
    Intervention Description
    Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss
    Primary Outcome Measure Information:
    Title
    Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
    Description
    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
    Time Frame
    12 months
    Title
    Ability of the CONVIVO system capture a readable image
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gordon Li
    Organizational Affiliation
    Stanford Universiy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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