This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGCohort 1: Determine the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Time frame: Up to 5 days
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Time frame: Up to 5 days
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Time frame: Up to 5 days
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)
Time frame: Up to 5 days
Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)
Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.
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Time frame: Up to 5 days
Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)
Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).
Time frame: Up to 5 days
Cohort 1: 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)
Clinically Significant Event (CSE) rate (tumor type-specific).
Time frame: Up to 5 days
Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Time frame: Up to 5 days