Use of Fluorescein Dye for the Removal of Brain Tumors
- Registration Number
- NCT02389530
- Lead Sponsor
- University of Pittsburgh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- Age of 18 or greater
- Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.
- History of adverse reaction to fluorescein.
- Emergent surgical procedure (consent not feasible).
- Creatinine of > 2.0 (drug is excreted renally).
- Known ongoing pregnancy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description interventional group Fluorescein All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal.
- Primary Outcome Measures
Name Time Method Adverse event assessment 3 years Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis
- Secondary Outcome Measures
Name Time Method Degree of tumoral resection 3 years Volumetric assessment of amount of tumor removed, compared to historical controls
Clinical status after surgery 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.
Trial Locations
- Locations (1)
UPMC Shadyside Hospital
🇺🇸Pittsburgh, Pennsylvania, United States