Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions

NCT03097627 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2015P002271
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple

Keywords

Indocyanine Green; Near-infrared imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  5 years

• Determine if intravenous ICG improves surgical resection

  5 years

Study Arms (1)

ICG Intervention

EXPERIMENTAL

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.

Drug: ICG Intervention; Device: Near Infrared Camera

Interventions

ICG Intervention DRUG

The intervention to be administered is the drug indocyanine green.

Also known as: Indocyanine Green

ICG Intervention

Near Infrared Camera DEVICE

The intervention to detect the administered drug, indocyanine green.

ICG Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yolonda Colson, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking in this study.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 31, 2017
• Study Start: February 1, 2016
• Primary Completion: October 28, 2016
• Study Completion: October 28, 2016
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)