Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00089310
Study type	Interventional
Source	Alliance for Clinical Trials in Oncology
Contact
Status	Completed
Phase	N/A
Start date	September 2004
Completion date	April 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms