Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass
• Intervention / Treatment: Device: Laser speckle contrast imaging (LSCI)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Miller, PhD; Phone Number: 9375728726; Email: dmiller@dynamiclight.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During Surgery

Collaborators and Investigators

• Sponsor: Dynamic Light
• Collaborators: St. Joseph's Hospital & Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Congenital Abnormalities; Neoplasms, Nerve Tissue; Pathological Conditions, Anatomical; Central Nervous System Neoplasms; Nervous System Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Meningeal Neoplasms; Arteriovenous Malformations; Vascular Fistula; Fistula; Aneurysm; Meningioma; Arteriovenous Fistula; Central Nervous System Vascular Malformations
• Other Study ID Numbers: LSCI-NSURG-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No