Intraoperative Imaging With Indocyanine Green

Overview

This is a Phase 1/2 study in patients presenting with suspected resectable solid tumors who are considered to be good surgical candidates and are at risk of local recurrence to evaluate the safety and efficacy of image guided surgery using indocyanine green for intramolecular imaging of solid tumors compared to standard of care.

Full Title of Study: “A Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Solid Tumors Compared to Standard of Care, (TumorGlow™)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 14, 2023

Interventions

  • Drug: Indocyanine Green
    • 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. Dose determined by PI based on tumor type, surgical timing, and previous assessments of signal-to-background ratio.

Arms, Groups and Cohorts

  • Experimental: Indocyanine Green

Clinical Trial Outcome Measures

Primary Measures

  • Assess Clinically Significant Events (CSEs)
    • Time Frame: Up to 5 days
    • A Clinically Significant Event (CSE) defined as the identification of tumor tissue not previously identified through MRI or the naked eye, of second window (up to 5 days) indocyanine green in detection of solid tumors and metastatic cancer cells in the lymph nodes, margins and satellite tumors using intraoperative near infrared imaging as compared to the standard of care.

Secondary Measures

  • Identify the Optimal Timing for Visualization of Indocyanine Green for Intraoperative Imaging in Solid Tumors by Cancer Type
    • Time Frame: Up to 5 days
    • The optimal timing for surgery following infusion of indocyanine green will be based on signal-to-background noise.
  • Identify the Safe/Effective Dose for Visualization of Indocyanine Green for Intraoperative Imaging in Solid Tumors by Cancer Type
    • Time Frame: Up to 5 days
    • The optimal dose will be based on optimal safety without toxicity for visualization of indocyanine green during intraoperative imaging in solid tumors.
  • Assessment of Safety
    • Time Frame: Up to 5 days
    • Assessment of side effects and/or potential toxicities that occur following infusion of indocyanine green.

Participating in This Clinical Trial

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:

  • Patients with a self-reported history of iodide allergies. – Vulnerable patient populations: unable to participate in the consent process. – History of uncontrolled hypertension (history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications). Of note, the decision to exclude patients with uncontrolled hypertension is based on our experience that the infusion may cause subtle increases in blood pressure during the infusion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Azra Din, 215-615-7980, azra.din@pennmedicine.upenn.edu

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