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临床试验/NCT00732563
NCT00732563已完成不适用

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

Roswell Park Cancer Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年7月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Recurrence rate at 2 years

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Recurrence rate at 2 years

时间窗: 2 years

Survival rate at 2 years

时间窗: 2 years

次要结局

  • Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe(Within 90 days)
  • Positive threshold of lymph node radioactivity(within 90 days)
  • Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging(Within 90 days)
  • Quality of life(At 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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