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

Primary Purpose

Solitary Pulmonary Nodules

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

near infrared fluorescence imaging (NIFI)

Indocyanine Green

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodules focused on measuring Indocyanine Green, Fluorescence Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Cardiothoracic Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Near Infrared Fluorescence Imaging with Indocyanine Green

Arm 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.

Outcomes

Primary Outcome Measures

Visibility in situ, white light

Visibility in situ, fluorescence

Nodule malignancy

Secondary Outcome Measures

Visibility ex vivo, white light

Visibility ex vivo, fluorescence

Full Information

NCT ID

NCT02851368

First Posted

July 5, 2016

Last Updated

November 19, 2017

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT02851368

Brief Title

Near Infrared Fluorescence Imaging With Indocyanine Green

Acronym

NIFI-ICG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solitary Pulmonary Nodules

Keywords

Indocyanine Green, Fluorescence Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Near Infrared Fluorescence Imaging with Indocyanine Green

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

near infrared fluorescence imaging (NIFI)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Indocyanine Green

Intervention Description

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

Primary Outcome Measure Information:

Title

Visibility in situ, white light

Time Frame