跳至主要内容
临床试验/NCT02383628
NCT02383628已完成不适用

Endoscopic Perfusion Utilizing ICG Fluorescence Technology

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
197
试验地点
1
主要终点
Efficacy as measured by observation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Less than 18 years of age
  • Iodine allergy
  • Shellfish allergy
  • Contrast allergy
  • Previous anaphylactic reaction to ICG
  • Anyone with any evidence of renal or hepatic dysfunction

结局指标

主要结局

Efficacy as measured by observation

时间窗: up to 52 weeks

compare efficacy of tissue perfusion with and without ICG Dye and light filter

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Gardner

Associate Professor

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验