Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Radiation: technetium-99
- Registration Number
- NCT00089310
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sentinal node mapping technetium-99 -
- Primary Outcome Measures
Name Time Method Sentinel node identification at time of procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Evanston Northwestern Healthcare - Evanston Hospital
🇺🇸Evanston, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States