Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097627
• Other study ID #: 2015P002271
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 13, 2017
• Last updated: December 11, 2017
• Start date: February 1, 2016
• Est. completion date: October 28, 2016

Study information

• Verified date: December 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 28, 2016
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG)	In this initial proof-of-concept pilot trial for patients undergoing surgical resection of suspicious intra-thoracic lesions, the investigators will demonstrate that IV ICG is a safe and feasible method for lesion localization. The investigators will demonstrate this across a variety of intra-thoracic pathology including primary lung cancer, pulmonary metastases, mesothelioma, mediastinal tumors, and potentially infectious sources such as aspergilloma. The investigators will measure safety based on number of participants with treatment-related adverse events as assessed by CTCAE v4.0	5 years
Secondary	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	The investigators will determine if lesions can be identified that were not seen on pre-operative imaging either because they were too small, missed, or ill-defined. In addition, many lesions such as vague ground glass opacities, which could represent scarring or a slow growing bronchoalveolar cancer, may be targeted with IV ICG, and thus aiding in the decision to resect a given lesion. Lymph nodes that contain disease may also uptake IV ICG. If a lymphadenectomy is indicated for standard of care, NIR positive nodes will be noted.	5 years
Secondary	Determine if intravenous ICG improves surgical resection	In cases of malignancy, performing an adequate oncologic resection (i.e. negative margins) or debulking is crucial to the prognosis of a patient with an intra-thoracic malignancy. Simultaneously, a surgeon must minimize the amount of resected healthy tissue to preserve lung function. Therefore, the investigators will assess the histologic status of the margin in all patients in which the lesion was ICG positive. The investigators will also maintain records of patients undergoing IV ICG to obtain intra-operative characteristics (i.e. successful lesion localization) and long-term events (i.e. local recurrence).	5 years