Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions (Fluoescein)

This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.

Study Overview

• Status: Unknown
• Conditions: Cerebrovascular Disorders; Intracranial Neoplasms
• Intervention / Treatment: Drug: Fluorescein Sodium

Detailed Description

The research design is a prospective clinical study. 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 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. 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.

No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (age ≥ 18)
• Diagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
• The patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein
• Patient or legally authorized representative provides written informed consent to enroll in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Patients; 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 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used).

Drug: Fluorescein Sodium; Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Intracerebral lesion	The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.	Particpants will be followed from enrollment into study which include atleast to 2 images and any other image done up to 1 year of scheudled follow up.

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Ravi Gandhi, MD, AdventHealth

Publications and helpful links

General Publications

• 1. Ciardella AP, Kaufman SR, Yannuzzi LA. The use of fluorescein angiography in acquired macular diseases. In: Tasman W, Jaeger EA, eds. Foundations of Clinical Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 113F.
• 2. Dithmar, Stefan, Holz, Frank G. Fluorescence Angiography in Ophthalmology. 2008, X, 224 p. 541 illus. in color.
• 3. Maguire JI, Federman JL. Intravenous fluorescein angiography. In: Tasman W, Jaeger EA, eds. Duane's Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 44.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Cerebrovascular Disorders
• Other Study ID Numbers: 684812