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

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 by Dana-Farber Cancer Institute

Sponsor:

Collaborators:

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00264602

First received: December 12, 2005

Last updated: January 28, 2016

Last verified: January 2016

History of Changes

Purpose

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	Intervention	Phase
Lung Cancer	Procedure: Near Infrared Imaging	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	114
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Intervention Details:

Dye injected into or around tumor at the time of surgery

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264602

Contacts


Contact: Yolonda L. Colson, MD, PhD	617-732-6648	ycolson@partners.org

Locations


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


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
Study First Received:	December 12, 2005
Last Updated:	January 28, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016

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