Clinical trial NCT00364663: The Utility and Cost-Effectiveness Analysis of 18F-FDG PETin Staging Potential Operable Non-Small Cell Lung Cancer
Official title: The Utility and Cost-Effectiveness Analysis of 18-Fluoro-2-Deoxyglucose Positron Emission Tomography in Staging Potential Operable Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
staging
18F-FDG PET
decision tree model
cost-effectiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ruoh-Fang Yen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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