Solitary Pulmonary Nodules Clinical Trial
Official title:
A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01465425 -
Extracolonic Findings on Computed Tomography (CT) Colonography
|
||
Enrolling by invitation |
NCT02531646 -
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
|
N/A | |
Completed |
NCT00922155 -
Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath
|
N/A |