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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

Page last updated: August 20, 2015

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