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Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5mg/kg of ICG, 24h before surgery | Active Comparator | 5mg/kg of indocyanine green, intravenously injection 24 hours before surgery |
|
| 1mg/kg of ICG, 24h before surgery | Experimental | 1mg/kg of indocyanine green, intravenously injection 24 hours before surgery |
|
| 5mg/kg of ICG, 48h before surgery | Experimental | 5mg/kg of indocyanine green, intravenously injection 48 hours before surgery |
|
| 1mg/kg of ICG, 48h before surgery | Experimental | 1mg/kg of indocyanine green, intravenously injection 48 hours before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Infusion of Indocyanine Green | Procedure | preoperatively infuse indocyanine green through peripheral vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma | We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios. | within 1 week after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Yang, MD | Contact | (+86) 18612978269 | yangfeng1007@sina.com | |
| Tiezheng Li, MD | Contact | (+86) 18811768786 | tiezhengli@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Jun, MD | Peking University People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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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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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |