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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 11, 2013
Last verified: September 2013
  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: Allocation: Randomized
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:


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 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Near Infrared Imaging
    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
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

No publications provided

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: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Lymphatic mapping
nodal targeting
indocyanine green
near infrared imaging

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014