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The Utility and Cost-Effectiveness Analysis of 18F-FDG PETin Staging Potential Operable Non-Small Cell Lung Cancer

2006年8月15日 更新者:National Taiwan University Hospital

The Utility and Cost-Effectiveness Analysis of 18-Fluoro-2-Deoxyglucose Positron Emission Tomography in Staging Potential Operable Non-Small Cell Lung Cancer

We plan to conduct a prospective study:

  1. to evaluate the accuracy of PET in staging patients with potentially operable non-small cell lung cancer;
  2. to evaluate the percentage of futile thoracotomy after PET is introduced in the routine staging modalities for NSCLC patient;
  3. to establish a decision tree model based on choices between conventional imaging only and additional PET imaging to analyze their cost-effectiveness.

研究概览

地位

未知

详细说明

Lung cancer has been a major health issue worldwide, including Taiwan. According to the data published by the Department of Health, Executive Yuan, Taiwan, 2004, lung cancer is already the leading cause of cancer-related death in Taiwan. Non-small cell lung cancer (NSCLC) represents approximately 75-85% of all primary lung tumors. The strongest prognostic factor for survival is whether the tumor can be completely resected. Surgical resection may be performed for those patients without distant or extended lymph node metastasis. Because of the significant morbidity and mortality for surgical procedure of lung cancer, it is therefore very important to identify and exclude those patients who can't benefit from surgical treatment. Conventional staging, using chest/brain X-ray computed tomography, abdominal echography and radionuclide bone scintigraphy, leads to futile thoracotomies in up to 50% of patients.

Since early 1990s, when 18F-FDG PET has emerged as a promising diagnostic imaging tool in nuclear medicine, a large number of studies have been reported without exception that PET is a better staging tool than CT for patients with NSCLC. However, due to the prohibitive cost, PET is not routinely used for the staging of NSCLC in Taiwan. The extra cost accruing from the introduction of this new technology has been the major concerns from the clinical physicians and health policy makers.

A number of economic evaluation studies overseas have shown that PET is cost-effective in NSCLC when added to conventional work-up. However, due to that the sensitivity and specificity of 18F-FDG PET in staging NSCLC, the cost structure of medical expense, the severity of disease for NSCLC patients when they first present in the hospital, may be different between different countries. To the best of our knowledge, there has been no report that provides a practical guide to introduce PET in staging NSCLC. A cost-effectiveness economic evaluation in Taiwan is thus in demand.

Patient eligibility:

Inclusion criteria: Patients with early NSCLC (stage I & II) Exclusion criteria: (1) patients who are pregnant (2) patients under 18 years old (3) patients who refuse surgical intervention (4) patients who have other known malignancy

研究类型

观察性的

注册

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾、100
        • 招聘中
        • National Taiwan University Hospital
        • 接触:
        • 首席研究员:
          • Ruoh-Fang Yen, MD, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • patients with non-small-cell lung cancer

Exclusion Criteria:

  • patients who are pregnant
  • patients who are under 18 years old
  • patients who do not undergone surgery
  • patients who have other known malignancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:确定的人口
  • 时间观点:其他

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ruoh-Fang Yen, MD, PhD、National Taiwan University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年8月1日

研究注册日期

首次提交

2006年8月15日

首先提交符合 QC 标准的

2006年8月15日

首次发布 (估计)

2006年8月16日

研究记录更新

最后更新发布 (估计)

2006年8月16日

上次提交的符合 QC 标准的更新

2006年8月15日

最后验证

2006年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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