Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

NCT02028325 | Terminated Phase 4 Results DMC

• 1 other identifier: GCBS-0003
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Adult Intracranial Neoplasm; Vascular: Intracranial

Outcome Measures

Primary Outcomes (1)

• Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging

  We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (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 fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.

  up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.

Study Arms (1)

Fluorescein Sodium

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 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.

Drug: Fluorescein Sodium

Interventions

Fluorescein Sodium DRUG

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.

Also known as: AK-Fluor

Fluorescein Sodium

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Sentara Norfolk General Hospital: collaborator

Study Sites (2)

Aaron Cohen-Gadol, MD

Indianapolis, Indiana, 46202, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Fluorescein; Fluoresceins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Aaron Cohen-Gadol, MD, MSc
• Organization: Indiana University

acohen@goodmancampbell.com

317-362-8760

Study Officials

• Aaron A Cohen, MD, MSc

  IU Health Methodist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016
• Results First Posted: September 29, 2016

Record last verified: 2016-10

Locations

US (2)