Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04165603
• Collaborator: (none)
• Enrollment: 352
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 29.4
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple	Procedure: Preoperative Infusion of Indocyanine Green	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
• Actual Study Start Date: Dec 18, 2018
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 5mg/kg of ICG, 24h before surgery 5mg/kg of indocyanine green, intravenously injection 24 hours before surgery	Procedure: Preoperative Infusion of Indocyanine Green; preoperatively infuse indocyanine green through peripheral vein
Experimental: 1mg/kg of ICG, 24h before surgery 1mg/kg of indocyanine green, intravenously injection 24 hours before surgery	Procedure: Preoperative Infusion of Indocyanine Green; preoperatively infuse indocyanine green through peripheral vein
Experimental: 5mg/kg of ICG, 48h before surgery 5mg/kg of indocyanine green, intravenously injection 48 hours before surgery	Procedure: Preoperative Infusion of Indocyanine Green; preoperatively infuse indocyanine green through peripheral vein
Experimental: 1mg/kg of ICG, 48h before surgery 1mg/kg of indocyanine green, intravenously injection 48 hours before surgery	Procedure: Preoperative Infusion of Indocyanine Green; preoperatively infuse indocyanine green through peripheral vein

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

• Study Director: Wang Jun, MD, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Wang, Chief，Thoracic Surgery Service, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT04165603
• Other Study ID Numbers: 2018PHB144-01
• First Posted: Nov 18, 2019
• Last Update Posted: Nov 18, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

No Results Posted as of Nov 18, 2019