LSCI-NSURG: Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT05028400
Collaborator
(none)
20
1
1
1.2
16

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laser speckle contrast imaging (LSCI)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Laser speckle contrast imaging (LSCI)Laser speckle contrast imaging (LSCI)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Mar 11, 2022
Actual Study Completion Date :
Mar 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Laser speckle contrast imaging (LSCI)

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.

Device: Laser speckle contrast imaging (LSCI)
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.

Outcome Measures

Primary Outcome Measures

  1. Agreement of ICG/FA and LSCI-findings [During surgery]

    Agreement of ICG/FA and LSCI-findings determinating flow in exposed vessels classified as no flow, delayed flow, normal flow

Secondary Outcome Measures

  1. Vessels examined with Laser speckle contrast imaging (LSCI) [During surgery]

    Vessels examined with Laser speckle contrast imaging (LSCI)

  2. Vessels examined with Indocyanine green angiography (ICGA) [During surgery]

    Vessels examined with Indocyanine green angiography (ICGA)

  3. Vessels examined with Fluorescein angiography (FA) [During surgery]

    Vessels examined with Fluorescein angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurosurgery Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Andreas Raabe, MD, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT05028400
Other Study ID Numbers:
  • LSCI-NSURG
First Posted:
Aug 31, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022