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.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms
• Intervention / Treatment: Drug: Fluorescein

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
interventional group; All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal.	Drug: Fluorescein; Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event assessment	Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tumoral resection	Volumetric assessment of amount of tumor removed, compared to historical controls	3 years
Clinical status after surgery	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.	3 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Johnathan Engh, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: glioma; neoplasms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: PRO14100616