Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer
technetium-99
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Diagnostic Study
Summary
Study start date: September 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
1. 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. 2. No prior therapy for this diagnosis. 3. No prior treatment with mediastinal radiation therapy. 4. Age ≥ 18 years of age. 5. ECOG performance status: 0-2.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
CCOP - Christiana Care Health Services
Newark, United StatesEvanston Northwestern Healthcare - Evanston Hospital
Evanston, United StatesVeterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, United States