Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Vascular: Intracranial Clinical Trial

— Fluorescein  

Official title:

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02028325
• Other study ID #: GCBS-0003
• Status: Terminated
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: February 29, 2016
• Start date: December 2013
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: October 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Intracranial Neoplasm
• Brain Neoplasms
• Vascular: Intracranial

Intervention

Drug:
• Fluorescein Sodium
All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Locations

Country	Name	City	State
United States	Aaron Cohen-Gadol, MD	Indianapolis	Indiana
United States	Sentara Norfolk General Hospital	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Sentara Norfolk General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Residual Brain Lesions	We will perform fluorescein angiography at surgery and assess if fluorescein angiography reveals any residual tumor or vascular lesions (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein angiography to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual aneurysm.	up to 1 week	Yes