Positron Emission Tomography (PET)/Computed Tomography (CT) and Roentgen in Lung Cancer: Evaluation of Patients in General Practice (PROLOG)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice|
- Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer [ Time Frame: min. two years of follow up ]
- 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 ]
|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)|
Radiation: PET/CT (low-dose)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675168
|Contact: Mie Jung Nielsen, MDemail@example.com|
|Contact: Poul Flemming Højlund Carlsen, MD, Professor, DMSc||0045-6541-2981|
|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 firstname.lastname@example.org|
|Odense, Fünen, Denmark|
|Contact: Nielsen, MD email@example.com|