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This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG Intervention | Experimental | The intervention to be administered is intravenous indocyanine green for intra-thoracic lesion localization and use of a near infrared camera to detect the ICG. All study subjects will receive this same intervention; there is only one arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG Intervention | Drug | The intervention to be administered is the drug indocyanine green. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG) | In this initial proof-of-concept pilot trial for patients undergoing surgical resection of suspicious intra-thoracic lesions, the investigators will demonstrate that IV ICG is a safe and feasible method for lesion localization. The investigators will demonstrate this across a variety of intra-thoracic pathology including primary lung cancer, pulmonary metastases, mesothelioma, mediastinal tumors, and potentially infectious sources such as aspergilloma. The investigators will measure safety based on number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities | The investigators will determine if lesions can be identified that were not seen on pre-operative imaging either because they were too small, missed, or ill-defined. In addition, many lesions such as vague ground glass opacities, which could represent scarring or a slow growing bronchoalveolar cancer, may be targeted with IV ICG, and thus aiding in the decision to resect a given lesion. Lymph nodes that contain disease may also uptake IV ICG. If a lymphadenectomy is indicated for standard of care, NIR positive nodes will be noted. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yolonda Colson, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
There is no plan at this time to share any individual participant data with other researchers.
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract 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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There is no masking in this study.
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| Near Infrared Camera | Device | The intervention to detect the administered drug, indocyanine green. |
|
| 5 years |
| Determine if intravenous ICG improves surgical resection | In cases of malignancy, performing an adequate oncologic resection (i.e. negative margins) or debulking is crucial to the prognosis of a patient with an intra-thoracic malignancy. Simultaneously, a surgeon must minimize the amount of resected healthy tissue to preserve lung function. Therefore, the investigators will assess the histologic status of the margin in all patients in which the lesion was ICG positive. The investigators will also maintain records of patients undergoing IV ICG to obtain intra-operative characteristics (i.e. successful lesion localization) and long-term events (i.e. local recurrence). | 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |