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

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ClinicalTrials.gov Identifier: NCT00364663
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2006
Last Update Posted : August 16, 2006
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Non Small Cell Lung Cancer

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


Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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 Start Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00364663


Contacts
Contact: Ruoh-Fang Yen, MD, PhD 886-2-23123456 ext 5581 rfyen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ruoh-Fang Yen, MD, PhD    886-2-23123456 ext 5581    rfyen@ha.mc.ntu.edu.tw   
Principal Investigator: Ruoh-Fang Yen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ruoh-Fang Yen, MD, PhD National Taiwan University Hospital
More Information

Publications:

ClinicalTrials.gov Identifier: NCT00364663     History of Changes
Other Study ID Numbers: 950307
NSC 95-2314-B-002 –268 –MY2
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: August 16, 2006
Last Verified: August 2006

Keywords provided by National Taiwan University Hospital:
NSCLC
staging
18F-FDG PET
decision tree model
cost-effectiveness

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms