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Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

Primary Purpose

Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ICG Intervention
Near Infrared Camera
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pulmonary Nodule, Solitary focused on measuring Indocyanine Green, Near-infrared imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 13, 2017
Last Updated
December 11, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03097627
Brief Title
Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
Official Title
Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
October 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
Keywords
Indocyanine Green, Near-infrared imaging

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
There is no masking in this study.
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
ICG Intervention
Other Intervention Name(s)
Indocyanine Green
Intervention Description
The intervention to be administered is the drug indocyanine green.
Intervention Type
Device
Intervention Name(s)
Near Infrared Camera
Intervention Description
The intervention to detect the administered drug, indocyanine green.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and feasibility) of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG)
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
5 years
Title
Determine if intravenous ICG improves surgical resection
Description
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).
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolonda Colson, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan at this time to share any individual participant data with other researchers.

Learn more about this trial

Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

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