Positron Emission Tomography (PET)/Computed Tomography (CT) and Roentgen in Lung Cancer: Evaluation of Patients in General Practice (PROLOG)
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|ClinicalTrials.gov 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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
- Radiation: PET/CT (low-dose)
400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scanOther Name: FDG
- 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 ]
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): NCT00675168
|Contact: Mie Jung Nielsen, MDfirstname.lastname@example.org|
|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 email@example.com|
|Odense, Fünen, Denmark|
|Contact: Nielsen, MD firstname.lastname@example.org|