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Co-investigator left facility. Decided not to enroll patients therefore.
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Akorn, Inc. | INDUSTRY |
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This research study is studying a new imaging method that will show lymph nodes in the lung during lung cancer surgery. The name of the study intervention involved in this study is:
-- The combination of the FluoSCOPE device and Indocyanine Green
This research study is a Pilot Study, which is the first time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved Indocyanine Green for your specific disease, but it has been approved for other uses.
In this research study, the investigators are interested in learning how a new investigational device, the FluoSCOPE, performs in the operating room. This study will also allow the investigators to optimize the settings of the imaging system. The investigators hope that this device, along with the local injection of Indocyanine Green around the tumor, will help find the sentinel lymph nodes in real-time during the surgery to remove lung cancer.
Although this is the first time the FluoSCOPE is being used in humans, the technology of near-infrared fluorescence imaging has been used for the detection of sentinel lymph nodes of patients with breast cancer, skin cancer and lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluoSCOPE device | Experimental | All study interventions will occur intraoperatively during the subject's planned surgery. No deviation from standard of care will be performed with the exception of the following specific interventions:-
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green (ICG) | Drug |
|
| |
| FluoSCOPE |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph node(s) is identified via NIR fluorescence imaging | Day one |
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-background ratio | signal-to-background ratio, determined by the relationship of field of view, fluence rate, and exposure time, is at least 2:1. | Day One |
| Number of Participants with Adverse Events |
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Inclusion Criteria:
All stages of lung cancer that would otherwise be undergoing thoracoscopic lung resection and mediastinal lymph node dissection would be eligible.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sidhu Gangadharan, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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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| Device |
|
| Day One |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |