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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near Infrared Fluorescence Imaging with Indocyanine Green | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| near infrared fluorescence imaging (NIFI) | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inderpal Sarkaria, MD | University of Pittsburgh Medical Center/UPP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Surgery | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indocyanine Green | Drug | Indocyanine Green will be administered intravenously 1 day prior to NIFI. |
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