Clinical trial NCT03097627: Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
Official title: Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Keywords: Indocyanine Green
Near-infrared imaging
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG)
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: Determine if intravenous ICG improves surgical resection
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Yolonda Colson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: