Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
- Conditions
- Pneumonia
- Interventions
- Radiation: ULD-CTRadiation: CXR
- Registration Number
- NCT03140163
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT) in order to prove it is more accurate in detecting pneumonia when comparing to standard conventional chest radiography.
- Detailed Description
* 200 subjects
* Each subject will undergo CXR and ULD-CT at the same day.
* Subjects subdivided into 3 groups \[high, moderate and low risk\], based on a laboratory finding(CRP), symptoms and physical examination.
* 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation)
* Radiologist will be blinded for subjects demographic data.
* All radiologist have to score how confidence they were on the finding of consolidation\[5point likert\].
* The investigators will perform a McNemar's test for evaluation. A two sided p-value of less than 0.05 will be considered to be statistically significant.
* Inter-observer variability will be evaluated by using a Fleiss Kappa test.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Suffering from pneumonia and referred by their GP
- Younger than 18
- Known pregnancy
- Not able to sign the Informed Consent document
- If not willing to be informed about additional findings
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects suffering from pneumonia CXR CXR ULD-CT Subjects suffering from pneumonia ULD-CT CXR ULD-CT
- Primary Outcome Measures
Name Time Method 5 point likert scale to evaluate the "level of confidence" of each radiologist 2 year - As described in "outcome 1" the radiologist judges the scans on existence of consolidation. After each judgement the radiologists has to fill in a questionaire \[5 point likert scale\] to score their level of confidence on the finding on whether or not they saw consolidation on the scan.
Risk assessment of having a pneumonia for each subject 2 year Subjects will be subdivided into 3 groups \[high, moderate and low risk\], based on a laboratory finding(CRP).
* CRP levels lower than 20mg/L \> low risk
* CRP levels between 20 and 100mg/l \> medium risk
* CRP levels higher than 100mg/l \> high riskThree different radiologists will be asked to fill in a questionaire on whether or not there is presence of consolidation (yes/no) on both ULD-CT, as well as on CXR. 2 years * 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation)
* Radiologist will be blinded for subjects demographic data.
- Secondary Outcome Measures
Name Time Method Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires 2 year All additional findings will be presented in a table.
for example:
Number of subjects with additional finding of atelectasis:
* ULD-CT (40 ULD-CT scans with atelectasis out of 100)
* CXR (25 CXR radiographs with atelectasis out of 100)
Number of subjects with additional finding of tumoral mass:
* ULD-CT (2 ULD-CT scans with tumoral mass out of 100)
* CXR (1 CXR radiographs with tumoral mass out of 100)
Number of subjects with additional finding of pleural effusion:
* ULD-CT (15 ULD-CT scans with pleural effusion out of 100)
* CXR (33 CXR radiographs with pleural effusion out of 100)In case the radiologist observes an additional finding, the radiologist has to fill in a questionaire on paper what kind of additional finding was seen: 2 year In case they see an additional finding, they have to fill in what kind of additional finding the have seen and write it down in the questionaire.
Example:
\[tumoral mass; pleural effusion; atelectasis; lymph nodules\].
- Additional findings will be subdivided in: atelectasis, pleural effusion, tree in bud, lymph nodes or tumoral mass.All 3 radiologist will be asked to write down on paper if they see an additional finding on either the ULD-CT or CXR 2 years Three different thoracic radiologist will judge the scans and fill in a questionaire if they see any additional finding (Yes/No).
Trial Locations
- Locations (1)
MUMC
🇳🇱Maastricht, Limburg, Netherlands