Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
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| ClinicalTrials.gov Identifier: NCT04865718 |
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Recruitment Status :
Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
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Sponsor:
University of Texas at Austin
Information provided by (Responsible Party):
University of Texas at Austin
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Aneurysm, Brain Arteriovenous Malformation of Brain Neurovascular Disorder | Diagnostic Test: ICGA imaging |
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow |
| Actual Study Start Date : | June 27, 2019 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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neurovascular surgery group
Subjects undergoing neurovascular surgery including aneurysm clipping
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Diagnostic Test: ICGA imaging
subjects undergoing intraoperative ICGA imaging |
Primary Outcome Measures :
- blood flow visible in laser speckle contrast images [ Time Frame: during surgical procedure ]Ability of laser speckle contrast images to reveal blood flow during surgery
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865718
Contacts
| Contact: Andrew Dunn, PhD | 512-232-2808 | adunn@utexas.edu | |
| Contact: Kristina Adrean, RN | 512-324-9999 ext 10025 | kadrean@ascension.org |
Locations
| United States, Texas | |
| Dell Seton Medical Center | Recruiting |
| Austin, Texas, United States, 78701 | |
| Contact: Kristina Adrean 512-324-9999 ext 10025 kadrean@ascension.org | |
Sponsors and Collaborators
University of Texas at Austin
| Responsible Party: | University of Texas at Austin |
| ClinicalTrials.gov Identifier: | NCT04865718 |
| Other Study ID Numbers: |
2018040045 |
| First Posted: | April 29, 2021 Key Record Dates |
| Last Update Posted: | April 29, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Intracranial Aneurysm Intracranial Arteriovenous Malformations Aneurysm Arteriovenous Malformations Vascular Diseases Cardiovascular Diseases Congenital Abnormalities Vascular Malformations |
Cardiovascular Abnormalities Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations |