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.
OBJECTIVES: Primary * 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. Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
46
0.25 mCi in 4 equal doses
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States
Sentinel node identification
Time frame: at time of procedure
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Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
...and 2 more locations