Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Not Applicable

• Conditions: Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple
• Interventions: Procedure: Preoperative Infusion of Indocyanine Green

• Registration Number: NCT04165603
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Study First Posted: 2019-11-18
• Last Update Posted: 2019-11-18
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 352

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5mg/kg of ICG, 48h before surgery	Preoperative Infusion of Indocyanine Green	5mg/kg of indocyanine green, intravenously injection 48 hours before surgery
1mg/kg of ICG, 24h before surgery	Preoperative Infusion of Indocyanine Green	1mg/kg of indocyanine green, intravenously injection 24 hours before surgery
5mg/kg of ICG, 24h before surgery	Preoperative Infusion of Indocyanine Green	5mg/kg of indocyanine green, intravenously injection 24 hours before surgery
1mg/kg of ICG, 48h before surgery	Preoperative Infusion of Indocyanine Green	1mg/kg of indocyanine green, intravenously injection 48 hours before surgery

Primary Outcome Measures

Name	Time	Method
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma	within 1 week after surgery	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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China