Near Infrared Fluorescence Imaging With Indocyanine Green

Solitary Pulmonary Nodules Clinical Trial

— NIFI-ICG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851368
• Other study ID #: UPCI 15-205
• Status: Completed
• Phase: Early Phase 1
• First received: July 5, 2016
• Last updated: November 19, 2017
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule
• Solitary Pulmonary Nodules

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Cardiothoracic Surgery	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visibility in situ, white light		Through study completion, an average of one year
Primary	Visibility in situ, fluorescence		Through study completion, an average of one year
Primary	Nodule malignancy		Through study completion, an average of one year
Secondary	Visibility ex vivo, white light		Through study completion, an average of one year
Secondary	Visibility ex vivo, fluorescence		Through study completion, an average of one year