NCT03097627

Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions.

Detailed description

* This study is designed to determine the safety and feasibility of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG), determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities, and determine if intravenous ICG improves surgical resection. * At the time of surgery, the indocyanine dye will be injected intravenously. The investigators will use a dose of 0.5 mg/kg administered prior to VATS. * The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lesions most likely to contain tumor cells.The surgeon will also look at lymph nodes to see if metastatic disease can be found in this location using this technique. The lymph nodes are processed to look for metastasis.

Conditions

• Pulmonary Nodule, Solitary
• Pulmonary Nodule, Multiple

Interventions

Type	Name	Description
DRUG	ICG Intervention	The intervention to be administered is the drug indocyanine green.
DEVICE	Near Infrared Camera	The intervention to detect the administered drug, indocyanine green.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-10-28
• Completion: 2016-10-28
• First posted: 2017-03-31
• Last updated: 2017-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study