Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Study Overview
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Brief Summary
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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.

Official Title
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Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Conditions
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Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple

Intervention / Treatment
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* Procedure: Preoperative Infusion of Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peripheral pulmonary solid nodules, with diameter 1-3 cm. Suitable for surgery and signed informed consent. Exclusion Criteria: Liver dysfunction. Allergic to indocyanine green. Can't tolerate thoracoscopic surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5mg/kg of ICG, 24h before surgery<br>5mg/kg of indocyanine green, intravenously injection 24 hours before surgery | Procedure: Preoperative Infusion of Indocyanine Green<br>* preoperatively infuse indocyanine green through peripheral vein<br>|
| Experimental: 1mg/kg of ICG, 24h before surgery<br>1mg/kg of indocyanine green, intravenously injection 24 hours before surgery | Procedure: Preoperative Infusion of Indocyanine Green<br>* preoperatively infuse indocyanine green through peripheral vein<br>|
| Experimental: 5mg/kg of ICG, 48h before surgery<br>5mg/kg of indocyanine green, intravenously injection 48 hours before surgery | Procedure: Preoperative Infusion of Indocyanine Green<br>* preoperatively infuse indocyanine green through peripheral vein<br>|
| Experimental: 1mg/kg of ICG, 48h before surgery<br>1mg/kg of indocyanine green, intravenously injection 48 hours before surgery | Procedure: Preoperative Infusion of Indocyanine Green<br>* preoperatively infuse indocyanine green through peripheral vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |