Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04165603
• Other study ID #: 2018PHB144-01
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: June 2021

Study information

• Verified date: November 2019
• Source: Peking University People's Hospital
• Contact: Feng Yang, MD
• Phone: (+86) 18612978269
• Email: yangfeng1007[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Procedure:
• Preoperative Infusion of Indocyanine Green
preoperatively infuse indocyanine green through peripheral vein

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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