Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Conditions
Adult Intracranial Neoplasm - Vascular: Intracranial
Conditions: official terms
Brain Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fluorescein Sodium
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.
Detailed Description
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 18 years or older.

- Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.

- The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively

- Patient or legally authorized representative provides written informed consent to enroll in this study.

Exclusion Criteria:

- Known allergic reaction to Fluorescein Sodium.

- Children.

- Prisoners.

- Students.

- Infection of the central nervous system or other sites.

- Hemodynamic instability or significant impairments in circulation.

- Concomitant treatment with other investigational drugs.

- Any uncontrolled condition unrelated to the neurosurgical disease.

- History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.

- Participation on other clinical trials during the last thirty days.

- Pregnant patients.

- Patients unable to discontinue medications that affect Fluorescein metabolism.
Locations
Aaron Cohen-Gadol, MD
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Aaron Cohen-Gadol, MD - 317-396-1300
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Status: Recruiting
Contact: Wylie H Zhu, MD - 757-388-6190
Start Date
December 2013
Completion Date
July 2016
Sponsors
Indiana University
Source
Indiana University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page