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

December 12, 2005
September 11, 2013
January 2009
September 2013   (final data collection date for primary outcome measure)
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 ]
To evaluate the safety and efficacy of near-infrared technology to guide therapeutic sentinel lymph node dissection in patients with lung cancer.
Complete list of historical versions of study NCT00264602 on ClinicalTrials.gov Archive Site
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Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

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.

  • 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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Cancer
Procedure: Near Infrared Imaging
Dye injected into or around tumor at the time of surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
114
January 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Yolonda L. Colson, MD, PhD 617-732-6648 ycolson@partners.org
United States
 
NCT00264602
05-219
No
Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
Principal Investigator: Yolonda L. Colson, MD, PhD Brigham and Women's Hospital
Dana-Farber Cancer Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP