TumorGlow Intraoperative Molecular Imaging (IMI)

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)

Conditions
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Tumor, Solid

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18 years of age or older. 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. Good operative candidate as determined by the treating physician and/or multidisciplinary team. Subject capable of giving informed consent. Exclusion Criteria: Subject unable to participate in the consent process. Vulnerable population including pregnant women, prisoners, and children. History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications) Patients with a self-reported history of iodide allergies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer. | Drug: Indocyanine Green<br>* 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.<br>|
| Experimental: Cohort 2<br>Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma. | Drug: Indocyanine Green<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Determine the safety of indocyanine green (all tumor types combined) | Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined). | 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. | 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. | 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) | 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. | Up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | Up to 5 days |