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Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

NCT02028325 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-11-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Sentara Norfolk General Hospital

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Aaron A Cohen, MD, MSc · IU Health Methodist Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028325 on ClinicalTrials.gov