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


N/A
18 Years
90 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Ruoh-Fang Yen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

950307

NCT ID:

NCT00364663

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC
  • staging
  • 18F-FDG PET
  • decision tree model
  • cost-effectiveness
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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