Second Window Imaging using Indocyanine Green (TumorGlow-CNS) to Identify Tumor Tissue During Surgery for Nervous System Tumors

PRIMARY OBJECTIVES:

I. To optimize same day dosing and timing of indocyanine green (ICG) for visualization of contrast-enhancing brain tumors by measuring tumor near-infrared (NIR) signal. (Part 1)

II. To determine the effect a tumor fluorophore has in surgical decision-making during brain tumor surgery. (Part 2)

III. To calculate true positives, by correlating “equivocal tissue” specimens which are positive in NIR with pathology. (Part 2)

SECONDARY OBJECTIVES:

I. To evaluate safety and toxicity, including review of vital signs and any reported or observed adverse events (AEs). (Part 1)

II. Using the recorded changes in resection decision based on NIR fluorescence after white light, to evaluate the pathological efficacy of changes in resection decision to no changes in decision. (Part 2)

III. Of all resected specimens, to compare the test accuracy of the surgeon’s identification of “likely tumor” and “unlikely tumor” under white light to the accuracy of “fluorescent” and “non-fluorescent” under NIR. (Part 2)

IV. To evaluate safety and toxicity, including review of vital signs and any reported or observed adverse events (AEs). (Part 2)

OUTLINE:

Patients receive ICG intravenously (IV) at induction of anesthesia prior to standard of care surgery and undergo NRI imaging on study. Patients also receive ICG injection at resected tissue margin and NRI imaging for further inspection and may undergo additional resection of remaining tumor tissue on study.