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

Primary Purpose

Adult Intracranial Neoplasm, Vascular: Intracranial

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluorescein Sodium
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Intracranial Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aaron Cohen-Gadol, MD
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescein Sodium

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2013
Last Updated
October 4, 2016
Sponsor
Indiana University
Collaborators
Sentara Norfolk General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02028325
Brief Title
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Acronym
Fluorescein
Official Title
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment. No new subjects had been enrolled for nearly a year.
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Sentara Norfolk General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Intracranial Neoplasm, Vascular: Intracranial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluorescein Sodium
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium
Other Intervention Name(s)
AK-Fluor
Intervention 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.
Primary Outcome Measure Information:
Title
Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron A Cohen, MD, MSc
Organizational Affiliation
IU Health Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aaron Cohen-Gadol, MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

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