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Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

NCT ID: NCT03097627

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-10-28

Brief Summary

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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

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* 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

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Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple

Keywords

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Indocyanine Green Near-infrared imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

There is no masking in this study.

Study Groups

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ICG Intervention

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.

Group Type EXPERIMENTAL

ICG Intervention

Intervention Type DRUG

The intervention to be administered is the drug indocyanine green.

Near Infrared Camera

Intervention Type DEVICE

The intervention to detect the administered drug, indocyanine green.

Interventions

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ICG Intervention

The intervention to be administered is the drug indocyanine green.

Intervention Type DRUG

Near Infrared Camera

The intervention to detect the administered drug, indocyanine green.

Intervention Type DEVICE

Other Intervention Names

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Indocyanine Green

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yolonda Colson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yolonda Colson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P002271

Identifier Type: -

Identifier Source: org_study_id