Trial Information

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

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.