Indocyanine Green for Solid Tumors

Overview

According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.

Full Title of Study: “A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green”

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: February 2017

Interventions

  • Drug: Indocyanine Green (ICG)

Arms, Groups and Cohorts

  • Experimental: ICG injection group
    • This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed.

Clinical Trial Outcome Measures

Primary Measures

  • The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
    • Time Frame: Before surgery

Secondary Measures

  • The number of participants that will have an adverse reaction to the ICG.
    • Time Frame: Day 1-Day 30

Participating in This Clinical Trial

Inclusion Criteria

1. Adult patients over 18 years of age

2. Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment

3. Good operative candidate as determined by the treating physician and multidisciplinary team

4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery

2. Subjects with a history of iodide allergies

3. Vulnerable patient populations

1. People who would be easily lost to follow up

2. Patients unable to participate in the consent process (children and neonates).

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
    • Principal Investigator: Sunil Singhall, Assistant Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab – University of Pennsylvania
  • Overall Official(s)
    • Sunil Singhal, M.D., Principal Investigator, University of Pennsylvania

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