Use of Fluorescein Dye for the Removal of Brain Tumors

Brain Neoplasms Clinical Trial

Official title:

Use of Fluorescein Dye for the Removal of Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389530
• Other study ID #: PRO14100616
• Status: Completed
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event assessment	Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis	3 years
Secondary	Degree of tumoral resection	Volumetric assessment of amount of tumor removed, compared to historical controls	3 years
Secondary	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