Near Infrared Fluorescence Imaging With Indocyanine Green (NIFI-ICG)

November 19, 2017 updated by: Inderpal Sarkaria, MD, University of Pittsburgh

A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Department of Cardiothoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Inderpal Sarkaria, MD, University of Pittsburgh Medical Center/UPP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 19, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCI 15-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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