Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Peking University

Status: Unknown

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Treatments: Procedure: Preoperative Infusion of Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT04165603

2018PHB144-01

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 4 patient groups

5mg/kg of ICG, 24h before surgery

Active Comparator group

Description:

5mg/kg of indocyanine green, intravenously injection 24 hours before surgery

Treatment:

Procedure: Preoperative Infusion of Indocyanine Green

1mg/kg of ICG, 24h before surgery

Experimental group

Description:

1mg/kg of indocyanine green, intravenously injection 24 hours before surgery

Treatment:

Procedure: Preoperative Infusion of Indocyanine Green

5mg/kg of ICG, 48h before surgery

Experimental group

Description:

5mg/kg of indocyanine green, intravenously injection 48 hours before surgery

Treatment:

Procedure: Preoperative Infusion of Indocyanine Green

1mg/kg of ICG, 48h before surgery

Experimental group

Description:

1mg/kg of indocyanine green, intravenously injection 48 hours before surgery

Treatment:

Procedure: Preoperative Infusion of Indocyanine Green