Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

Study Description

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Brief Summary:

The primary purpose of this study is to determine if we can identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: Near Infrared Imaging	Phase 1

Detailed Description:

• This study is designed to determine the feasibility, safety amd dosing for indocyanine green and near-infrared fluorescent light in order to maximize the near infrared-guided detection of tumor-specific sentinel lymph nodes during the routine surgery for early stage lung cancer when the tumor and nearby lymph nodes are removed.
• At the time of surgery, the indocyanine dye will be injected into or around the patient's tumor. We are using a dose approximately 10,000 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will remove the lymph nodes near the tumor, as is standard for lung surgery, and we will look at these lymph nodes with near-infrared fluorescence.
• The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes.
• Since the first question of this study is to determine the smallest dose of indocyanine green that can be used safely for near-infrared detection of the lymph nodes, not all subjects will receive the same dose. The most any person will receive is 1/3 of a teaspoon.
• A five year observation period begins following the operation during which surgeons and physicians will examine the patient and order certain studies to look for evidence of regrowth of the tumor.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	57 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Masking Description:	There is no masking in this study. All study subjects will receive the same intervention.
Primary Purpose:	Diagnostic
Official Title:	Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
Actual Study Start Date :	February 18, 2009
Actual Primary Completion Date :	September 1, 2017
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Near Infrared Imaging; The intervention to be administered is indocyanine green dye.	Drug: Near Infrared Imaging; Dye injected into or around tumor at the time of surgery; Other Names: Indocyanine Green; Sentinel Lymph Node

Outcome Measures

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Primary Outcome Measures :

1. To evaluate the safety and efficacy of near-infrared technology to guide therapeutic sentinel lymph node dissection in patients with lung cancer. [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
• Surgically resectable lung cancer
• N2 lymph nodes negative on PET scan or mediastinoscopy
• Age > or equal to 18 years of age
• Men, women of non-child bearing age or women with a negative pregnancy test

Exclusion Criteria:

• Patient does not want to undergo subsequent surgical resection
• Medical condition such as uncontrolled infection or cardiac disease that, i the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient.
• T4 or N2 disease
• Pre-operative spirometry that suggests they cannot undergo resection of their primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
• Iodide or seafood allergy
• Pregnant or lactating women

Contacts and Locations

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Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:	Yolonda L. Colson, MD, PhD	Brigham and Women's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yolonda L. Colson, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00264602 History of Changes
Other Study ID Numbers:	05-219
First Posted:	December 13, 2005
Last Update Posted:	December 20, 2017
Last Verified:	December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute:

Lymphatic mapping; nodal targeting; indocyanine green; near infrared imaging

Additional relevant MeSH terms:

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