A Contrast Agent, Fluorescein, for the Identification of Tumor Tissue during Surgery in Patients with Low or High Grade Glioma
- 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 legally authorized representative (LAR)
- No serious associated psychiatric illnesses
- 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 liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [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 180 umol/L within 30 days prior to surgery
- Inability to comply with the photosensitivity precautions associated with the study
I. To evaluate the performance of fluorescein as an intraoperative biomarker for tumor tissue in surgical patients with a clinical diagnosis of high and low grade glioma when the fluorescence is visualized by the neurosurgeon through the operating microscope.
I. Comparing the performance of fluorescein as visualized by the neurosurgeon to that of
Ia. Contrast-enhancement on coregistered preoperative magnetic resonance (MR) scans.
Ib. Intraoperative ALA-induced PpIX fluorescence both visualized by the neurosurgeon and measured quantitatively with an intraoperative probe in patients with a clinical diagnosis of high grade glioma.
II. Comparing the diagnostic performance of fluorescein as visualized by the neurosurgeon to that of concentrations of fluorescein measured quantitatively with an intraoperative probe and between patients with a clinical diagnosis of either high grade glioma or low grade glioma receiving fluorescein + ALA versus fluorescein alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm A: Approximately 3 hours prior to surgery, patients receive ALA orally (PO), then receive fluorescein sodium intravenously (IV) at time of anesthesia induction (or up to 3 hours prior to tumor resection). If fluorescein fluorescence is substantially dissipated during surgery, patients may receive a second dose of fluorescein sodium.
ARM B: Patients receive fluorescein sodium IV at time of anesthesia induction (or up to 3 hours prior to tumor resection). If fluorescein fluorescence is substantially dissipated during surgery, patients may receive a second dose of fluorescein sodium.
Trial Phase Phase II
Trial Type Diagnostic
Dartmouth Hitchcock Medical Center
David William Roberts
- Primary ID D12090
- Secondary IDs NCI-2020-02082, D-HH eIRB: STUDY00024247
- Clinicaltrials.gov ID NCT02691923