Use of Fluorescein Dye for the Removal of Brain Tumors

NCT02389530 | Completed

• 1 other identifier: PRO14100616
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms

Keywords

glioma; neoplasms

Outcome Measures

Primary Outcomes (1)

• Adverse event assessment

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

  3 years

Secondary Outcomes (2)

• Degree of tumoral resection

  3 years

• Clinical status after surgery

  3 years

Study Arms (1)

interventional group

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

Drug: Fluorescein

Interventions

Fluorescein DRUG

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

interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or above pending elective removal of an intraparenchymal brain tumor.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Johnathan Engh, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 17, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2017-11

Locations

US (1)