Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

NCT02478346 | Unknown Phase 4

• 1 other identifier: 684812
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebrovascular Disorders; Intracranial Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

All Patients

EXPERIMENTAL

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

Interventions

Fluorescein Sodium DRUG

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.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (3)

• 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.

  BACKGROUND

• 2. Dithmar, Stefan, Holz, Frank G. Fluorescence Angiography in Ophthalmology. 2008, X, 224 p. 541 illus. in color.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Brain Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Ravi Gandhi, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherlynn Basignani, BSN,RN,CCRC

CONTACT

407-303-3247; cherlynn.basignani@flhosp.org

Gabriella Anderson, BA, CCRC

CONTACT

407-303-3214; gabriella.anderson@flhosp.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 23, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

US (1)