Use of Fluorescein Dye for the Removal of Brain Tumors

August 1, 2018 updated by: University of Pittsburgh
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 3 years
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
Time Frame: 3 years
Volumetric assessment of amount of tumor removed, compared to historical controls
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14100616

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe