Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Radiation: technetium-99


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with clinical stage I lung cancer for whom surgical resection is planned are eligible. Histologic confirmation of lung cancer is not required prior to registration or surgical exploration. Preoperative mediatinoscopy is allowed but not required in those patients with indications for mediatinoscopy. It is preferred that that mediatinoscopy be done at a different setting (prior to registration), but the procedure may be done at the same setting as the lobectomy. No prior therapy for this diagnosis. No prior treatment with mediastinal radiation therapy. Age ≥ 18 years of age. ECOG performance status: 0-2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinal node mapping<br> | Radiation: technetium-99<br>* 0.25 mCi in 4 equal doses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel node identification |  | at time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I non-small cell lung cancer