Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05028400 |
| Other study ID # |
LSCI-NSURG |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
March 11, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
University Hospital Inselspital, Berne |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 neurosurgery, 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.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to
visualize flow in vessels in real time and continuously without the need for contrast agents.
In LSCI, the tissue of interest is illuminated with low power laser light at red or near
infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera.
The resulting images are laser speckle patterns and a computer processes the images to
produce speckle contrast images, which are images of the motion within the field of view (ie,
blood flow).
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI
compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded
automatically intraoperatively in each patient before, during, and after ICGA and/or FA in
the same surgical field of view to guarantee comparability of the methods.
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 neurosurgery, 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.
Neurosurgery involves the treatment of blood-vessel related pathologies within the brain,
like intracranial aneurysms, arteriovenous malformations and dural arteriovenous fistulas,
but also the handling of vessels during brain tumor resections. For these operations,
assessment of flow in vessels is of paramount importance. So far, the surgeon can not "see"
blood flowing inside the artery or vein. Real-time 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 flow in arteries during
surgery is indocyanine green angiography (ICGA) and fluorescein angiography (FA), which
involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of
the dye to determine which vessels are perfused. Both ICGA and FA provide only a punctual
view of perfusion over several seconds, being far away from a continuous assessment.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to
visualize flow in vessels in real time and continuously without the need for contrast agents.
In LSCI, the tissue of interest is illuminated with low power laser light at red or near
infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera.
The resulting images are laser speckle patterns and a computer processes the images to
produce speckle contrast images, which are images of the motion within the field of view (ie,
blood flow).
With these properties LSCI has the potential to deliver for the first time continuous
visualisation of blood flow in large and small vessels and to overcome limitations of ICGA
and FA. LSCI is an established technique for studies of CBF and has predominantly been used
to study microcirculation of the cerebral cortex during neurosurgical procedures. However,
the spatial resolution in the clinical setting and its accuracy compared to ICGA and FA are
unclear.
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI
compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded
automatically intraoperatively in each patient before, during, and after ICGA and/or FA in
the same surgical field of view to guarantee comparability of the methods.
