Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15232, United States
NCT Number: NCT02851368
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Pittsburgh, Pennsylvania, 15232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 will be administered intravenously 1 day prior to NIFI.
Time frame: Through study completion, an average of one year
Time frame: Through study completion, an average of one year
Time frame: Through study completion, an average of one year
Time frame: Through study completion, an average of one year
Time frame: Through study completion, an average of one year
University of Pittsburgh
Other
A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
Acronym: NIFI-ICG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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