Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

NCT04865718 | Unknown

• 1 other identifier: 2018040045
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood 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 cerebral blood flow 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. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.

Conditions

Aneurysm, Brain; Arteriovenous Malformation of Brain; Neurovascular Disorder

Outcome Measures

Primary Outcomes (1)

• blood flow visible in laser speckle contrast images

  Ability of laser speckle contrast images to reveal blood flow during surgery

  during surgical procedure

Study Arms (1)

neurovascular surgery group

Subjects undergoing neurovascular surgery including aneurysm clipping

Diagnostic Test: ICGA imaging

Interventions

ICGA imaging DIAGNOSTIC_TEST

subjects undergoing intraoperative ICGA imaging

neurovascular surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adults planned for craniotomy procedures such as planned resections for brain tumor or neurovascular procedure such as aneurysm or arteriovenous malformation

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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Seton Medical Center

Austin, Texas, 78701, United States

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Andrew Dunn, PhD

CONTACT

512-232-2808; adunn@utexas.edu

Kristina Adrean, RN

CONTACT

512-324-9999; kadrean@ascension.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: June 27, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)