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Positron Emission Tomography (PET)/Computed Tomography (CT) and Roentgen in Lung Cancer: Evaluation of Patients in General Practice (PROLOG)

This study is not yet open for participant recruitment.
Verified by Odense University Hospital, May 2008

Sponsored by: Odense University Hospital
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00675168
  Purpose

The prognosis of lung cancer depends much on the stage of the disease at the time of diagnosis. Only 16 % of lung cancer can be offered curative intended surgery. Chest x-ray is the gate-keeper in lung cancer diagnosis, but it has a miss rate of 20-60 %. A false negative chest x-ray often causes prolonged delay in diagnosis - often months.

Recently a "48 hour diagnosis guaranty" has been implemented, which helps accelerate the system delay (delay from referral to diagnosis). But chest x-ray is still the gate-keeper; if the chest x-ray is negative further examination ceases.

PET/CT has a higher sensitivity (96 %), than chest x-ray. In the latter years only little improvement in the survival rate of lung cancer has been made. Screening studies is currently been performed, but it's time for innovative thinking. PET/CT has established its place in the staging of lung cancer. But studies like this may help to place PET/CT in the chain of examination making it more cost-beneficial.

The overall aim of this study is to improve patient course with earlier diagnosis of lung cancer.


Condition Intervention Phase
Lung Cancer
Radiation: PET/CT (low-dose)
Phase IV

MedlinePlus related topics:   CT Scans    Cancer    Lung Cancer    X-Rays   

Drug Information available for:   Deoxyglucose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study
Official Title:   PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer [ Time Frame: min. two years of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive/negative predictive values of chest x-ray and PET/CT Operability - surrogate for survival Numbers of false positive PET/CT Numbers of false negative PET/CT Numbers of invasive procedures Cost-effectiveness [ Time Frame: min. two years of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:   1700
Study Start Date:   May 2008
Estimated Study Completion Date:   June 2012
Estimated Primary Completion Date:   June 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Radiation: PET/CT (low-dose)
    400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scan
Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Pt. referred from general practice to a chest x-ray
  • age 60-80 years
  • current or former smoker

Exclusion Criteria:

  • previously diagnosed with lung cancer
  • contraindications to PET/CT
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675168

Contacts
Contact: Mie Jung Nielsen, MD     45-6541-2981     mie.nielsen@ouh.regionsyddanmark.dk    
Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc     45-6541-2981    

Locations
Denmark, Funen
Department of Nuclear Medicine    
      Odense, Funen, Denmark, 5000

Sponsors and Collaborators
Odense University Hospital
  More Information


Responsible Party:   Odense University Hospital, Department of Nuclear Medicine ( Mie Jung Nielsen, MD )
Study ID Numbers:   PROLOG
First Received:   May 6, 2008
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00675168
Health Authority:   Denmark: The Danish National Committee on Biomedical Research Ethics;   Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Lung Cancer  
PET/CT  
Diagnosis  

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Deoxyglucose

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2008




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