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CompletedNCT05305378Updated Aug 7, 2024

Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

An observational study in Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass, sponsored by Dynamic Light. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Dynamic Light · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during the course of surgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough. During neurosurgery, vessel occlusion may occur either inadvertently or as a necessary part of the procedure, and yet current technologies do not adequately predict the consequences of such occlusion. Real-time CBF 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 CBF 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.

Patients will undergo standard craniotomy surgery. The surgical procedures will not be altered in any way by the proposed studies. As long as it is standard of care, neuromonitoring, intraoperative angiogram, and Indocyanine green angiography will be performed by the surgeon. LSCI imaging will be performed at the discretion of the surgeon following exposure of the cortex and will vary from patient to patient depending on the neurosurgical procedure. The LSCI measurements will not add any time to the surgery nor affect the normal operation of the neurosurgical microscope.

02

Conditions studied

  • Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass
03

In context

Aneurysm

956 studies on the registry are indexed under Aneurysm; 171 are open to participants now.

This study's enrollment of 8 is below the median of 150 across 441 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

This is the only study on the registry with Dynamic Light as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults (18 years or older).
  2. Size of craniotomy at least 2 cm.
  3. Possibility of intraoperative ICGA.
  4. Able to render written informed consent.
  5. Women of child-bearing potential must have a negative pre-op pregnancy test.

Exclusion criteria

Exclusion Criteria:

  1. Patients unable to legally consent.
  2. Patients with impaired cognitive function.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Interventions

  • DeviceLaser speckle contrast imaging (LSCI)

    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.

06

What researchers measure

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.

    Time frame: During Surgery

07

Study locations

1 site
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05305378
Lead sponsor
Dynamic Light
Collaborators
Barrow Neurological Institute
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Apr 20, 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Aug 7, 2024

Study contacts

Michael T. Lawton, MD
principal investigator · Barrow Neurological Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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