This phase II trial studies how well a contrast agent called fluorescein works compared to aminolevulinic acid (ALA) in identifying tumor tissue during surgery in patients with low or high grade glioma. Fluorescein is a contrast agent which glows a yellowish-green color and may help surgeons identify the tumor. ALA is produced naturally in the body and helps to make the hemoglobin in blood. As part of this process, ALA is turned into another molecule called protoporphyrin IX (PpIX) which glows a reddish-pink color. More PpIX can be produced by tumor cells than is produced by the normal cells in the brain if extra ALA is given a few hours before surgery. The purpose of this trial is to learn whether fluorescein may help surgeons identify the brain tumor during surgery and to compare fluorescein to ALA in identifying brain tumors during surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT02691923.
Locations matching your search criteria
United States
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterStatus: Active
Contact: David William Roberts
Phone: 603-650-5214
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorDavid William Roberts
