This pilot phase I/II trial studies the best way to give indocyanine green solution and to see how well it works in identifying tumors in the brain or spine during image-guided surgery. Detecting indocyanine green solution by using a hand-held light source and camera system may be a useful tool to identify central nervous system tumors from normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02710240.
PRIMARY OBJECTIVES:
I. To determine whether indocyanine green solution (ICG) uptake and expression in central nervous system (CNS) tumor correlates with co-registered regions of elevated choline (Cho), relative cerebral blood volume (rCBV), volume transfer constant of contrast agent (Ktrans) and contrast enhancement identified through magnetic resonance (MR) imaging and spectroscopy.
SECONDARY OBJECTIVE:
I. To determine through post hoc analyses if pathology findings correlate with ICG uptake.
OUTLINE: Patients are assigned to 1 of 2 cohorts based on tumor location.
COHORT I:
Patients with extra-axial brain tumors receive indocyanine green solution intravenously (IV) over 40 minutes and undergo standard of care MRI the day before image-guided surgery. Patients then undergo intraoperative near-infrared (NIR) imaging and standard of care surgical resection. Video images of the patient’s tumor will be taken 5 to 10 minutes, before resection, during resection, and after resection to record indocyanine green solution activity. After surgery based on standard techniques is completed, patients undergo stereotactic biopsy of any suspected areas of residual or abnormal tissue at the discretion of the surgeon.
COHORT II:
Patients with intra-axial glial tumors receive indocyanine green solution IV over 40 minutes, undergo conventional MRI, and undergo 3-dimensional-echo planar spectroscopic imaging (3D-EPSI) the day before image-guided surgery. Patients then undergo NIR imaging and standard of care surgical resection. Video images of the patient’s tumor will be taken 5 to 10 minutes, before resection, during resection, and after resection to record indocyanine green solution activity. After surgery based on standard techniques is completed, patients undergo stereotactic biopsy of any suspected areas of residual or abnormal tissue at the discretion of the surgeon.
After completion of study treatment, patients are followed up for 5 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJohn Young K. Lee
