Use of Fluorescein Dye for the Removal of Brain Tumors

NCT ID: NCT02389530

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.

Detailed Description

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Conditions

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Brain Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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interventional group

All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal.

Fluorescein

Intervention Type DRUG

Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.

Interventions

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Fluorescein

Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age of 18 or greater
2. Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.

Exclusion Criteria

1. History of adverse reaction to fluorescein.
2. Emergent surgical procedure (consent not feasible).
3. Creatinine of \> 2.0 (drug is excreted renally).
4. Known ongoing pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnathan Engh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

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UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO14100616

Identifier Type: -

Identifier Source: org_study_id

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