A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cohort 1
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.
Intervention: Indocyanine Green (Drug)
Cohort 2
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.
Intervention: Indocyanine Green (Drug)
Outcomes
Primary Outcomes
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
Time Frame: Up to 5 days
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.
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
Time Frame: Up to 5 days
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
Time Frame: Up to 5 days
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.
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
Time Frame: Up to 5 days
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)
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)
Time Frame: Up to 5 days
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.
Secondary Outcomes
- Cohort 1: Provide preliminary estimates of the 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)(Up to 5 days)
- Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)(Up to 5 days)