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

University of Pittsburgh

Status and phase: Completed; Early Phase 1

Conditions: Solitary Pulmonary Nodules

Treatments: Drug: Indocyanine Green; Device: near infrared fluorescence imaging (NIFI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02851368

UPCI 15-205

Details and patient eligibility

About

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 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Near Infrared Fluorescence Imaging with Indocyanine Green

Other group

Description:

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.

Treatment:

Device: near infrared fluorescence imaging (NIFI)

Drug: Indocyanine Green