Brain Neoplasms
Conditions
Keywords
glioma, neoplasms
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.
Interventions
DRUGFluorescein
Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.
Sponsors
University of Pittsburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event assessment | 3 years | Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed