Endoscopic Perfusion Utilizing ICG Fluorescence Technology



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2015
End Date:June 2018
Contact:Benita Valappil, MPH
Email:valappilb2@upmc.edu
Phone:4128641744

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The main objective of the study is to evaluate the efficacy of indocyanine green (ICG)
endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients
with pituitary and intracranial tumors and treatment of vascular abnormalities such as
aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the
additional visual information supplied during the treatment of these pathologies.

Over the past decade, a technique widely used by ophthalmologists to assess retinal blood
flow, near-infrared ICG angiography, has been applied to neurosurgical patients undergoing a
wide variety of cerebrovascular procedures. This technique offers the advantage of real-time
visualization of cerebral blood flow through the operating microscope at the time the
procedure is being performed. Indocyanine green is an ideal agent for imaging vessels as it
is tightly bound to plasma albumin, has a short half-life, and maintains an acceptable safety
profile. Furthermore, the excitation and emission profiles for ICG lie in the near-infrared
wavelengths, which allow penetration and imaging of vessels below a few millimeters of
tissue.

Patients with either an aneurysm, compressive syndromes or pituitary and intracranial tumor
will be enrolled in the study. By taking advantage of the natural fluorescence of indocyanine
green (ICG) within the red spectrum and applying a light filter to the endoscope eyepiece and
camera it will show as to whether this technique provides adequate visual information to
differentiate perfusion in tumor and surrounding structures and to evaluate normal vessels
for aneurysm and compressive syndromes procedures.

Inclusion Criteria:

- Patient population would include those patients with pituitary tumors, intracranial
tumors, aneurysms, and normal tissue adjacent to tumors to clarify normal from
abnormal. Also, patients with compressive syndromes to ensure patency of normal
vessels. This would be all patients undergoing endoscopic surgery, both endonasal and
open (retromastoid or transcranial).

Exclusion Criteria:

- Less than 18 years of age

- Iodine allergy

- Shellfish allergy

- Contrast allergy

- Previous anaphylactic reaction to ICG

- Pregnant

- Anyone with any evidence of renal or hepatic dysfunction
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Gardner Paul, MD
Phone: 412-864-1744
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