Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02691923 : Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
PhasePhase 2
AgesMin: 21 Years Max: N/A
Eligibility
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
studies.

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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02691923      |      Link to official Clinicaltrials.gov listing
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