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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00675168
Recruitment Status : Unknown
Verified February 2009 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : May 8, 2008
Last Update Posted : February 19, 2009
Information provided by:
Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Radiation: PET/CT (low-dose) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice
Study Start Date : May 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer X-Rays

Intervention Details:
  • Radiation: PET/CT (low-dose)
    400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scan
    Other Name: FDG

Primary Outcome Measures :
  1. Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer [ Time Frame: min. two years of follow up ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00675168

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Contact: Mie Jung Nielsen, MD 0045-6541-2981
Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc 0045-6541-2981

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Department of Nuclear Medicine Not yet recruiting
Odense, Funen, Denmark, 5000
Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc    45-6541-2981      
Contact: Allan Johansen, MD, Head of Department    45-6541-2981      
Principal Investigator: Mie Jung Nielsen, MD         
Odense, Fünen, Denmark
Contact: Nielsen   
Odense, Fünen, Denmark
Contact: Nielsen, MD   
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Mie Jung Nielsen, MD, Odense University Hospital, Department of Nuclear Medicine Identifier: NCT00675168     History of Changes
Other Study ID Numbers: PROLOG
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009
Keywords provided by Odense University Hospital:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases