Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery (LSCI-NSURG)
Primary Purpose
Aneurysm, AVM, Dural Arteriovenous Fistula
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laser speckle contrast imaging (LSCI)
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysm
Eligibility Criteria
Inclusion Criteria:
- Vascular pathology of the brain or brain tumors requiring elective microsurgical treatment (e.g., aneurysm, arteriovenous malformation, dural arteriovenous fistula, glioma, meningioma, metastasis)
- Adults (18 years or older)
- Informed consent signed by the subject
Exclusion Criteria:
• Patients lacking capacity to consent
Sites / Locations
- Department of Neurosurgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser speckle contrast imaging (LSCI)
Arm Description
LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
Outcomes
Primary Outcome Measures
Agreement of ICG/FA and LSCI-findings
Agreement of ICG/FA and LSCI-findings determinating flow in exposed vessels classified as no flow, delayed flow, normal flow
Secondary Outcome Measures
Vessels examined with Laser speckle contrast imaging (LSCI)
Vessels examined with Laser speckle contrast imaging (LSCI)
Vessels examined with Indocyanine green angiography (ICGA)
Vessels examined with Indocyanine green angiography (ICGA)
Vessels examined with Fluorescein angiography (FA)
Vessels examined with Fluorescein angiography
Full Information
NCT ID
NCT05028400
First Posted
August 24, 2021
Last Updated
April 11, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05028400
Brief Title
Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery
Acronym
LSCI-NSURG
Official Title
Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
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
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 neurosurgery, 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.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to visualize flow in vessels in real time and continuously without the need for contrast agents. In LSCI, the tissue of interest is illuminated with low power laser light at red or near infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera. The resulting images are laser speckle patterns and a computer processes the images to produce speckle contrast images, which are images of the motion within the field of view (ie, blood flow).
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
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 neurosurgery, 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.
Neurosurgery involves the treatment of blood-vessel related pathologies within the brain, like intracranial aneurysms, arteriovenous malformations and dural arteriovenous fistulas, but also the handling of vessels during brain tumor resections. For these operations, assessment of flow in vessels is of paramount importance. So far, the surgeon can not "see" blood flowing inside the artery or vein. Real-time flow 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 flow in arteries during surgery is indocyanine green angiography (ICGA) and fluorescein angiography (FA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Both ICGA and FA provide only a punctual view of perfusion over several seconds, being far away from a continuous assessment.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to visualize flow in vessels in real time and continuously without the need for contrast agents. In LSCI, the tissue of interest is illuminated with low power laser light at red or near infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera. The resulting images are laser speckle patterns and a computer processes the images to produce speckle contrast images, which are images of the motion within the field of view (ie, blood flow).
With these properties LSCI has the potential to deliver for the first time continuous visualisation of blood flow in large and small vessels and to overcome limitations of ICGA and FA. LSCI is an established technique for studies of CBF and has predominantly been used to study microcirculation of the cerebral cortex during neurosurgical procedures. However, the spatial resolution in the clinical setting and its accuracy compared to ICGA and FA are unclear.
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
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
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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser speckle contrast imaging (LSCI)
Arm Type
Experimental
Arm Description
LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
Intervention Type
Device
Intervention Name(s)
Laser speckle contrast imaging (LSCI)
Intervention Description
LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
Primary Outcome Measure Information:
Title
Agreement of ICG/FA and LSCI-findings
Description
Agreement of ICG/FA and LSCI-findings determinating flow in exposed vessels classified as no flow, delayed flow, normal flow
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Vessels examined with Laser speckle contrast imaging (LSCI)
Description
Vessels examined with Laser speckle contrast imaging (LSCI)
Time Frame
During surgery
Title
Vessels examined with Indocyanine green angiography (ICGA)
Description
Vessels examined with Indocyanine green angiography (ICGA)
Time Frame
During surgery
Title
Vessels examined with Fluorescein angiography (FA)
Description
Vessels examined with Fluorescein angiography
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Vascular pathology of the brain or brain tumors requiring elective microsurgical treatment (e.g., aneurysm, arteriovenous malformation, dural arteriovenous fistula, glioma, meningioma, metastasis)
Adults (18 years or older)
Informed consent signed by the subject
Exclusion Criteria:
• Patients lacking capacity to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Raabe, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery
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