Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

NCT05305378 | Completed

• 1 other identifier: LSCI-NSURG-03
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Laser speckle contrast imaging (LSCI) DEVICE

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.

Eligibility Criteria

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

Study Population

Patients seeking treatment at the Barrow Neurological Institute with pathologies that require a craniotomy of at least 2 cm in diameter.

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to legally consent.
• Patients with impaired cognitive function.

Sponsors & Collaborators

• Dynamic Light: lead
• Barrow Neurological Institute: collaborator

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

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

• Michael T. Lawton, MD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 20, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)