Near Infrared Fluorescence Imaging With Indocyanine Green

Early Phase 1

Completed

• Conditions: Solitary Pulmonary Nodules
• Interventions: Device: near infrared fluorescence imaging (NIFI); Drug: Indocyanine Green

• Registration Number: NCT02851368
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-08-01
• Study Start: 2016-11
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-19
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Near Infrared Fluorescence Imaging with Indocyanine Green	near infrared fluorescence imaging (NIFI)	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.
Near Infrared Fluorescence Imaging with Indocyanine Green	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.

Primary Outcome Measures

Name	Time	Method
Visibility in situ, fluorescence	Through study completion, an average of one year
Nodule malignancy	Through study completion, an average of one year
Visibility in situ, white light	Through study completion, an average of one year

Secondary Outcome Measures

Name	Time	Method
Visibility ex vivo, white light	Through study completion, an average of one year
Visibility ex vivo, fluorescence	Through study completion, an average of one year

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States