Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery

NCT05028400 | Completed

• 1 other identifier: LSCI-NSURG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysm; AVM; Dural Arteriovenous Fistula; Glioma; Meningioma; Metastasis

Outcome Measures

Primary Outcomes (1)

• 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

  During surgery

Secondary Outcomes (3)

• Vessels examined with Laser speckle contrast imaging (LSCI)

  During surgery

• Vessels examined with Indocyanine green angiography (ICGA)

  During surgery

• Vessels examined with Fluorescein angiography (FA)

  During surgery

Study Arms (1)

Laser speckle contrast imaging (LSCI)

EXPERIMENTAL

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)

Interventions

Laser speckle contrast imaging (LSCI) DEVICE

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.

Laser speckle contrast imaging (LSCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients lacking capacity to consent

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurosurgery

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aneurysm; Central Nervous System Vascular Malformations; Glioma; Meningioma; Neoplasm Metastasis

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nervous System Malformations; Nervous System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Andreas Raabe, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Laser speckle contrast imaging (LSCI)

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: February 1, 2022
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)