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Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

Primary Purpose

Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser speckle contrast imaging (LSCI)
Sponsored by
Dynamic Light
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults (18 years or older).
  2. Size of craniotomy at least 2 cm.
  3. Possibility of intraoperative ICGA.
  4. Able to render written informed consent.
  5. Women of child-bearing potential must have a negative pre-op pregnancy test.

Exclusion Criteria:

  1. Patients unable to legally consent.
  2. Patients with impaired cognitive function.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Agreement of ICG and LSCI.
    Agreement of ICG and LSCI observations to determine flow in exposed vessels classified as no flow, delayed flow, or normal flow.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    March 22, 2022
    Sponsor
    Dynamic Light
    Collaborators
    St. Joseph's Hospital & Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05305378
    Brief Title
    Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
    Official Title
    Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 15, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    October 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dynamic Light
    Collaborators
    St. Joseph's Hospital & Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the proposed study is to investigate the usefulness of laser speckle contrast imaging (LSCI) compared to indocyanine green angiography (ICGA). We will collect data from a wide variety of neurovascular surgical procedures to determine when the technology is the most clinically useful. The intraoperative LSCI system provides high resolution images of blood flow in real-time without tissue contact and without the need for an exogenous contrast agent. Further study is needed to gain a better understanding of the use of the technique during surgery, but initial results suggest that the ability to identify blood flow changes with immediate feedback to the surgeon could be a significant advantage during many procedures.
    Detailed Description
    Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during the course of surgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough. During neurosurgery, vessel occlusion may occur either inadvertently or as a necessary part of the procedure, and yet current technologies do not adequately predict the consequences of such occlusion. Real-time CBF visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing CBF during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Patients will undergo standard craniotomy surgery. The surgical procedures will not be altered in any way by the proposed studies. As long as it is standard of care, neuromonitoring, intraoperative angiogram, and Indocyanine green angiography will be performed by the surgeon. LSCI imaging will be performed at the discretion of the surgeon following exposure of the cortex and will vary from patient to patient depending on the neurosurgical procedure. The LSCI measurements will not add any time to the surgery nor affect the normal operation of the neurosurgical microscope.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Laser speckle contrast imaging (LSCI)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Laser speckle contrast imaging (LSCI)
    Intervention Description
    LSCI videos will be recorded intraoperatively in each patient before, during, and after ICGA in the same surgical field of view to guarantee comparability of the methods.
    Primary Outcome Measure Information:
    Title
    Agreement of ICG and LSCI.
    Description
    Agreement of ICG and LSCI observations to determine flow in exposed vessels classified as no flow, delayed flow, or normal flow.
    Time Frame
    During Surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults (18 years or older). Size of craniotomy at least 2 cm. Possibility of intraoperative ICGA. Able to render written informed consent. Women of child-bearing potential must have a negative pre-op pregnancy test. Exclusion Criteria: Patients unable to legally consent. Patients with impaired cognitive function.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Miller, PhD
    Phone
    9375728726
    Email
    dmiller@dynamiclight.ai

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

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