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Near Infrared Fluorescence Imaging With Indocyanine Green

NCT ID: NCT02851368

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Solitary Pulmonary Nodules

Keywords

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Indocyanine Green Fluorescence Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Near Infrared Fluorescence Imaging with 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.

Group Type OTHER

near infrared fluorescence imaging (NIFI)

Intervention Type 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.

Indocyanine Green

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

Indocyanine Green

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Inderpal Sarkaria, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inderpal Sarkaria, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center/UPP

Locations

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Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCI 15-205

Identifier Type: -

Identifier Source: org_study_id