Indocyanine Green for Imaging of Solid Tumors during Surgery Compared to Standard of Care

PRIMARY OBJECTIVES:

I. To determine the safety of indocyanine green (all tumor types combined). (Cohort 1)

II. To identify optimal dosing and timing of indocyanine green before surgery, and camera combination (tumor type-specific). (Cohort 1)

III. To determine the sensitivity and specificity of indocyanine green (tumor type-specific). (Cohort 2)

IV. To confirm the efficacy of indocyanine green used with near infrared (NIR) fluorescent imaging as measured by clinically significant event (CSE) rate (tumor type-specific). (Cohort 2)

SECONDARY OBJECTIVES:

I. To provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific). (Cohort 1)

II. To provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific). (Cohort 1)

III. To confirm the safety of indocyanine green (all tumor types combined). (Cohort 2)

OUTLINE: Patients scheduled to undergo surgery for the following cancers are assigned to Cohort I: Glioma, thymoma, parathyroid adenoma, mesothelioma, colorectal cancer metastatic to the lung, and breast, colon, rectal, head and neck, ovarian, prostate, renal cell, thyroid, esophageal, pancreas, and stomach cancers. Patients scheduled to undergo surgery for the following cancers are assigned to Cohort II: Non-small cell lung cancer, sarcoma metastatic to the lung, brain meningioma.

COHORT I: Patients receive indocyanine green intravenously (IV) over 40-60 minutes 1, 2, 3, 4, or 5 days prior to surgery, or on the day of surgery. Patients then undergo NIR fluorescence imaging over 5-10 minutes during surgery.

COHORT II: Patients receive indocyanine green IV over 40-60 minutes 1 or 2 days before surgery, or on the day of surgery. Patients then undergo NIR fluorescence imaging over 5-10 minutes during surgery.