Trial Information

Intraoperative Sentinel Node Mapping In 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.

PROJECTED ACCRUAL: A total of 57-150 patients will be accrued for this study within 2 years.