Use of Fluorescein Dye for the Removal of Brain Tumors

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

History of adverse reaction to fluorescein.
Emergent surgical procedure (consent not feasible).
Creatinine of > 2.0 (drug is excreted renally).
Known ongoing pregnancy.

Treatment and study plan

Fluorescein

Drug

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

Primary outcomes

Adverse event assessment

Time frame: 3 years

Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis

Secondary outcomes

Degree of tumoral resection

Time frame: 3 years

Volumetric assessment of amount of tumor removed, compared to historical controls
Clinical status after surgery

Time frame: 3 years

Assessment of new deficit in speech, motor function, sensation or vision based on post-operative neurological examination: NIH stroke scale scores will be measured for all participants pre- and post-operatively.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Mar 17, 2015
Registry last updated: Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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