Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

• Status: Terminated
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Sentara Norfolk General Hospital

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.