Positron Emission Tomography (PET)/Computed Tomography (CT) and Roentgen in Lung Cancer: Evaluation of Patients in General Practice
PROLOG
PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice
1 other identifier
interventional
1,700
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 lung-cancer
Started May 2008
Longer than P75 for phase_4 lung-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 19, 2009
February 1, 2009
2.1 years
May 6, 2008
February 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer
min. two years of follow up
Secondary Outcomes (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
min. two years of follow-up
Interventions
400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scan
Eligibility Criteria
You may qualify if:
- Pt. referred from general practice to a chest x-ray
- age 60-80 years
- current or former smoker
You may not qualify if:
- previously diagnosed with lung cancer
- contraindications to PET/CT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Nuclear Medicine
Odense, Funen, 5000, Denmark
Unknown Facility
Odense, Fünen, Denmark
Unknown Facility
Odense, Fünen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2008
First Posted
May 8, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2012
Last Updated
February 19, 2009
Record last verified: 2009-02