Aneurysm, BrainNCT04865718
Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
An observational study of Aneurysm, Brain and Arteriovenous Malformation of Brain, run by Andrew Dunn at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Brain, Arteriovenous Malformation of Brain, Neurovascular Disorder
- What is being tested?
- ICGA imaging
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to Dec 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adults (18 years or older).
- Size of craniotomy at least 2 cm.
- Possibility of intraoperative ICGA.
- Able to render written informed consent.
Who cannot join
- Patients unable to legally consent.
- Patients with impaired cognitive function.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- ICGA imaging
- Medical subject headings
- Intracranial Aneurysm, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGA imagingDiagnostic test
subjects undergoing intraoperative ICGA imaging
| Study group | Role | What they receive |
|---|---|---|
| neurovascular surgery group | Subjects undergoing neurovascular surgery including aneurysm clipping Receives: Diagnostic Test: ICGA imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood flow visible in laser speckle contrast images
Ability of laser speckle contrast images to reveal blood flow during surgery
Measured: during surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start27 Jun 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: lack of grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Dunn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Dunn, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865718
- Sponsor's protocol ID
- 2018040045
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT04865718
- Acronym / sponsor ID
- 2018040045
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of grant funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andrew DunnUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurovascular surgery group | – | Diagnostic Test: ICGA imagingSubjects undergoing neurovascular surgery including aneurysm clipping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Adults (18 years or older).
- Size of craniotomy at least 2 cm.
- Possibility of intraoperative ICGA.
- Able to render written informed consent.
Key exclusion criteria (2 listed)
- Patients unable to legally consent.
- Patients with impaired cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICGA imagingsubjects undergoing intraoperative ICGA imaging | Diagnostic test | neurovascular surgery group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, Brain and Arteriovenous Malformation of Brain, run by Andrew Dunn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood flow visible in laser speckle contrast images (time frame: during surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.