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

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ClinicalTrials.gov Identifier: NCT02028325
Recruitment Status : Terminated (Lack of enrollment. No new subjects had been enrolled for nearly a year.)
First Posted : January 7, 2014
Results First Posted : September 29, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Sentara Norfolk General Hospital
Information provided by (Responsible Party):
Aaron Cohen-Gadol, Indiana University

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.

Condition or disease Intervention/treatment Phase
Adult Intracranial Neoplasm Vascular: Intracranial Drug: Fluorescein Sodium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Study Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fluorescein Sodium
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
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.
Other Name: AK-Fluor




Primary Outcome Measures :
  1. Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging [ 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028325


Locations
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United States, Indiana
Aaron Cohen-Gadol, MD
Indianapolis, Indiana, United States, 46202
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Indiana University
Sentara Norfolk General Hospital
Investigators
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Principal Investigator: Aaron A Cohen, MD, MSc IU Health Methodist Hospital

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Responsible Party: Aaron Cohen-Gadol, Neurosurgeon, Indiana University
ClinicalTrials.gov Identifier: NCT02028325     History of Changes
Other Study ID Numbers: GCBS-0003
First Posted: January 7, 2014    Key Record Dates
Results First Posted: September 29, 2016
Last Update Posted: November 8, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases