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Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

P

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

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

Trial contacts and locations

1

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Central trial contact

Feng Yang, MD; Tiezheng Li, MD

Data sourced from clinicaltrials.gov

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