Clinical Trial Details
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NCT02691923 : Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
PhasePhase 2
AgesMin: 21 Years Max: N/A
Inclusion Criteria:

1. Preoperative diagnosis of either presumed first-time low or high grade glioma
(astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and
glioblastoma multiforme).

2. Tumor judged to be suitable for open cranial resection based on preoperative imaging

3. Valid informed consent by subject or subject's LAR.

4. No serious associated psychiatric illnesses.

5. Age = 21 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.

2. History of hypersensitivity to fluorescein.

3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins,
photodermatosis, exfoliative dermatitis.

4. History of liver disease within the last 12 months.

5. 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.

6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.

7. Inability to comply with the photosensitivity precautions associated with the study.
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