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
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.
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Procedure: thoracic surgical procedure
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer|
- Survival rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Recurrence rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Positive threshold of lymph node radioactivity [ Time Frame: within 90 days ] [ Designated as safety issue: No ]
- Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
- Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||January 2017|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732563
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Chukwumere E. Nwogu, MD||Roswell Park Cancer Institute|