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
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|ClinicalTrials.gov Identifier: NCT00732563|
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : October 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer|
|Actual Study Start Date :||July 16, 2008|
|Actual Primary Completion Date :||June 29, 2012|
|Actual Study Completion Date :||July 26, 2017|
- Survival rate at 2 years [ Time Frame: 2 years ]
- Recurrence rate at 2 years [ Time Frame: 2 years ]
- Positive threshold of lymph node radioactivity [ Time Frame: within 90 days ]
- 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 ]
- Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging [ Time Frame: Within 90 days ]
- Quality of life [ Time Frame: At 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|