Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

Trial ID: NCT02691923

Interventional - Phase 2 - Active, not recruiting

This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.

Conditions

• Brain Cancer

Interventions

• Fluorescein
• Fluorescein + ALA

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.

Sponsor

David W. Roberts, National Institute of Neurological Disorders and Stroke (NINDS), Carl Zeiss Meditec, Inc.

Source: ClinicalTrials.gov

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