Fludeoxyglucose F 18 in Detecting Lymph Node Metastasis in Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer. PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

Detailed Description
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OBJECTIVES: Primary Determine the positive threshold of lymph node radioactivity after fludeoxyglucose F 18, utilizing the gamma probe, in patients with resectable stage I or II non-small cell lung cancer. Compare the accuracy of detecting thoracic lymph node metastases using positron emission tomography-computed tomography (PET-CT) versus the intra-operative hand-held gamma probe in these patients. Determine the ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging in these patients. Assess the clinical relevance of the gamma probe-detected lymph node metastases by measuring patient survival, tumor recurrence, impact on patient quality of life, and cost. OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies. Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life. After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.

Official Title
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Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: chemotherapy
* Procedure: lymphadenectomy
* Procedure: neoadjuvant therapy
* Procedure: quality-of-life assessment
* Procedure: therapeutic conventional surgery
* Procedure: thoracic surgical procedure
* Radiation: fludeoxyglucose F 18
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer Stage I-II disease Resectable disease Planning to undergo surgical resection No tumors that are not fludeoxyglucose F 18 (FDG)-avid on PET scan PATIENT CHARACTERISTICS: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No previous allergic reaction to fludeoxyglucose F 18 No contraindication to a pulmonary lobectomy and lymphadenectomy PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chemotherapy|Given IV and Orally|
|Procedure: lymphadenectomy|Removal of lymph nodes|
|Procedure: neoadjuvant therapy|Tumor reduction|
|Procedure: quality-of-life assessment|Correlative Study|
|Procedure: therapeutic conventional surgery|Treatment for cancer|
|Procedure: thoracic surgical procedure|removal of tissue|
|Radiation: fludeoxyglucose F 18|given IV|
|Radiation: radiation therapy|undergoing radiotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate at 2 years |  | 2 years | 
| Recurrence rate at 2 years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive threshold of lymph node radioactivity |  | within 90 days | 
| Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe |  | Within 90 days | 
| Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging |  | Within 90 days | 
| Quality of life |  | At 3 years | 

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