Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Treatments: Device: Near Infrared Camera; Drug: ICG Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03097627

2015P002271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon.
• 18 years of age or older
• Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion criteria

• Subjects who do not wish to have subsequent surgical resection
• A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
• Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor.
• Iodide or seafood allergy

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

ICG Intervention

Experimental group

Description:

The intervention to be administered is intravenous indocyanine green for intra-thoracic lesion localization and use of a near infrared camera to detect the ICG. All study subjects will receive this same intervention; there is only one arm.

Treatment:

Device: Near Infrared Camera

Drug: ICG Intervention