Clinical trial NCT02851368: Near Infrared Fluorescence Imaging With Indocyanine Green
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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Solitary Pulmonary Nodules
Keywords: Indocyanine Green
Fluorescence Imaging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visibility in situ, white light
timeFrame: Through study completion, an average of one year
measure: Visibility in situ, fluorescence
timeFrame: Through study completion, an average of one year
measure: Nodule malignancy
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Visibility ex vivo, white light
timeFrame: Through study completion, an average of one year
measure: Visibility ex vivo, fluorescence
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Department of Cardiothoracic Surgery
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center/UPP
name: Inderpal Sarkaria, MD
role: PRINCIPAL_INVESTIGATOR
References: