Near Infrared Fluorescence Imaging With Indocyanine Green

Overview

This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.

Full Title of Study: “A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules”

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: November 2017

Detailed Description

This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.

Interventions

  • Device: near infrared fluorescence imaging (NIFI)
    • The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery.
  • Drug: Indocyanine Green
    • Indocyanine Green will be administered intravenously 1 day prior to NIFI.

Arms, Groups and Cohorts

  • Other: Near Infrared Fluorescence Imaging with Indocyanine Green
    • Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure.

Clinical Trial Outcome Measures

Primary Measures

  • Visibility in situ, white light
    • Time Frame: Through study completion, an average of one year
  • Visibility in situ, fluorescence
    • Time Frame: Through study completion, an average of one year
  • Nodule malignancy
    • Time Frame: Through study completion, an average of one year

Secondary Measures

  • Visibility ex vivo, white light
    • Time Frame: Through study completion, an average of one year
  • Visibility ex vivo, fluorescence
    • Time Frame: Through study completion, an average of one year

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s).
  • Women and men at least 18 years of age
  • Subjects must have a CT scan of the chest within 8 weeks of surgery

Exclusion Criteria

  • Previous thoracic surgery
  • Inoperable tumor/nodule
  • Unable to tolerate surgery
  • History of allergies to iodides
  • Breast feeding
  • Pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Inderpal Sarkaria, MD, MD – University of Pittsburgh
  • Overall Official(s)
    • Inderpal Sarkaria, MD, Principal Investigator, University of Pittsburgh Medical Center/UPP

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