Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Vascular: Intracranial; Adult Intracranial Neoplasm

Treatments: Drug: Fluorescein Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02028325

GCBS-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Fluorescein Sodium

Experimental group

Description:

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.

Treatment:

Drug: Fluorescein Sodium