A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
Overview
- Phase
- Early Phase 1
- Intervention
- near infrared fluorescence imaging (NIFI)
- Conditions
- Solitary Pulmonary Nodules
- Sponsor
- University of Pittsburgh
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Visibility in situ, fluorescence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Inderpal Sarkaria, MD
MD
University of Pittsburgh
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
Arms & Interventions
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.
Intervention: near infrared fluorescence imaging (NIFI)
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.
Intervention: Indocyanine Green
Outcomes
Primary Outcomes
Visibility in situ, fluorescence
Time Frame: Through study completion, an average of one year
Nodule malignancy
Time Frame: Through study completion, an average of one year
Visibility in situ, white light
Time Frame: Through study completion, an average of one year
Secondary Outcomes
- Visibility ex vivo, white light(Through study completion, an average of one year)
- Visibility ex vivo, fluorescence(Through study completion, an average of one year)