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Completed

NCT Number: NCT02851368

Near Infrared Fluorescence Imaging With Indocyanine Green

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

near infrared fluorescence imaging (NIFI)

Device

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.

Indocyanine green

Drug

Indocyanine Green will be administered intravenously 1 day prior to NIFI.

Primary outcomes

  1. Visibility in situ, white light

    Time frame: Through study completion, an average of one year

  2. Visibility in situ, fluorescence

    Time frame: Through study completion, an average of one year

  3. Nodule malignancy

    Time frame: Through study completion, an average of one year

Secondary outcomes

  1. Visibility ex vivo, white light

    Time frame: Through study completion, an average of one year

  2. Visibility ex vivo, fluorescence

    Time frame: Through study completion, an average of one year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: NIFI-ICG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2016
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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