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
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lymphatic Metastasis
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): chemotherapy; lymphadenectomy; neoadjuvant therapy; quality-of-life assessment; therapeutic conventional surgery; thoracic surgical procedure; fludeoxyglucose F 18; radiation therapy
Intervention type(s): Drug; Procedure; Procedure; Procedure; Procedure; Procedure; Radiation; Radiation
Intervention description(s): Given IV and Orally; Removal of lymph nodes; Tumor reduction; Correlative Study; Treatment for cancer; removal of tissue; given IV; undergoing radiotherapy
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer