Near Infrared Fluorescence Imaging With Indocyanine Green

NCT02851368 | Completed Early Phase 1 DMC

• 1 other identifier: UPCI 15-205
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Solitary Pulmonary Nodules

Keywords

Indocyanine Green; Fluorescence Imaging

Outcome Measures

Primary Outcomes (3)

• Visibility in situ, white light

  Through study completion, an average of one year

• Visibility in situ, fluorescence

  Through study completion, an average of one year

• Nodule malignancy

  Through study completion, an average of one year

Secondary Outcomes (2)

• 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

Study Arms (1)

Near Infrared Fluorescence Imaging with Indocyanine Green

OTHER

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); Drug: Indocyanine Green

Interventions

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.

Near Infrared Fluorescence Imaging with Indocyanine Green

Indocyanine Green DRUG

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

Near Infrared Fluorescence Imaging with Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous thoracic surgery
• Inoperable tumor/nodule
• Unable to tolerate surgery
• History of allergies to iodides
• Breast feeding
• Pregnant

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Inderpal Sarkaria, MD

  University of Pittsburgh Medical Center/UPP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: August 1, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)