Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer
RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes.
PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer|
- Sentinel node identification [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||April 2009|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
|Experimental: Sentinal node mapping||
0.25 mCi in 4 equal doses
- Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer.
- Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure.
- Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes.
- Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes.
- Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure.
- Determine the percentage of patients undergoing this procedure with "skip metastases" pattern (NZ) sentinel lymph nodes.
OUTLINE: This is a multicenter study.
Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid. At least 10 minutes later, patients undergo sentinel lymph node mapping using a gamma probe. Patients then undergo sentinel lymph node dissection and tumor resection. Pathology assays are performed using sentinel lymph node tissue, including hematoxylin and eosin staining, serial sections, and immunohistochemistry using the AE1/AE3/PCK2b cytokeratin antibody.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 57-150 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089310
|United States, Delaware|
|Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Illinois|
|Evanston Northwestern Healthcare - Evanston Hospital|
|Evanston, Illinois, United States, 60201-1781|
|United States, Missouri|
|Veterans Affairs Medical Center - Columbia (Truman Memorial)|
|Columbia, Missouri, United States, 65201|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Elmhurst Hospital Center|
|Elmhurst, New York, United States, 11373|
|Queens Cancer Center of Queens Hospital|
|Jamaica, New York, United States, 11432|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|SUNY Upstate Medical University Hospital|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Veterans Affairs Medical Center - Asheville|
|Asheville, North Carolina, United States, 28805|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Thomas A. D'Amico, MD||Duke University|