Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

Aneurysm, Brain Clinical Trial

Official title:

Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865718
• Other study ID #: 2018040045
• Status: Recruiting
• Start date: June 27, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Texas at Austin
• Contact: Andrew Dunn, PhD
• Phone: 512-232-2808
• Email: adunn[@]utexas.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18 years or older).
• Size of craniotomy at least 2 cm.
• Possibility of intraoperative ICGA.
• Able to render written informed consent.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Brain
• Arteriovenous Malformation of Brain
• Arteriovenous Malformations
• Intracranial Aneurysm
• Intracranial Arteriovenous Malformations
• Neurovascular Disorder

Intervention

Diagnostic Test:
• ICGA imaging
subjects undergoing intraoperative ICGA imaging

Locations

Country	Name	City	State
United States	Dell Seton Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood flow visible in laser speckle contrast images	Ability of laser speckle contrast images to reveal blood flow during surgery	during surgical procedure