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
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 10/20/2017 |
Start Date: | July 16, 2008 |
End Date: | July 26, 2017 |
Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
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.
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.
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.
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.
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
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