Solitary Pulmonary Nodules
Conditions
Keywords
Indocyanine Green, Fluorescence Imaging
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.
Interventions
DEVICEnear 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.
DRUGIndocyanine Green
Indocyanine Green will be administered intravenously 1 day prior to NIFI.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visibility in situ, white light | Through study completion, an average of one year |
| Visibility in situ, fluorescence | Through study completion, an average of one year |
| Nodule malignancy | Through study completion, an average of one year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed