Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions



Status:Terminated
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2013
End Date:October 2016

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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 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.

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.
We found this trial at
2
sites
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Indianapolis, Indiana 46202
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Indianapolis, IN
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