Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
Brain Cancer
About this trial
This is an interventional diagnostic trial for Brain Cancer focused on measuring High Grade Glioma, Low Grade Glioma, Brain Tumor
Eligibility Criteria
Inclusion Criteria:
- Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Valid informed consent by subject or subject's LAR.
- No serious associated psychiatric illnesses.
- Age ≥ 21 years old.
Exclusion Criteria:
- Pregnant women or women who are breast feeding.
- History of hypersensitivity to fluorescein.
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
- History of liver disease within the last 12 months.
- Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery.
- Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
- Inability to comply with the photosensitivity precautions associated with the study.
Sites / Locations
- Sally B MansurRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Fluorescein
Fluorescein + ALA
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure.
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure. ALA administered orally at 20mg/kg approximately 3 hours before surgery.