Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Information source: Indiana University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Intracranial Neoplasm; Vascular: Intracranial
Intervention: Fluorescein Sodium (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s): Aaron A Cohen, MD, MSc, Principal Investigator, Affiliation: IU Health Methodist Hospital
Overall contact: Aaron Cohen-Gadol, MD, Phone: 317-396-1300
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.
Clinical Details
Official title: Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of Residual Brain 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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 and Contacts
Aaron Cohen-Gadol, MD, Phone: 317-396-1300
Aaron Cohen-Gadol, MD, Indianapolis, Indiana 46202, United States; Recruiting Aaron Cohen-Gadol, MD, Phone: 317-396-1300
Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States; Recruiting Wylie H Zhu, MD, Phone: 757-388-6190 Judith C Taylor-Fishwick, Phone: 757-388-1926
Additional Information
Starting date: December 2013
Last updated: April 15, 2015
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