Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
| Registry | NCT03140163, acronym ULTRACHEST |
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 100 (Actual) |
| Sponsor | Maastricht University Medical Center (Other) |
| Conditions | Pneumonia |
| Interventions | ULD-CT, CXR (Radiation) |
| Dates | start 2016-09-01, primary completion 2019-04-01 (estimated), completion 2019-12-01 (estimated), first posted 2017-05-04, last updated 2018-11-20 |
| Locations | 1 site in Netherlands |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Subjects suffering from pneumonia | Experimental | Radiation: ULD-CT; Radiation: CXR | CXR ULD-CT |
- ULD-CT (Radiation), also known as Ultra Low Dose chest CT: Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
- CXR (Radiation), also known as Conventional chest X ray: Conventional chest radiograph
+Outcome measures
Primary outcomes
- Three 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.
- 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 risk
- 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.
Secondary outcomes
- 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).
- 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.
- 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)
+Eligibility
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria:
* Suffering from pneumonia and referred by their GP
Exclusion Criteria:
* Younger than 18
* Known pregnancy
* Not able to sign the Informed Consent document
* If not willing to be informed about additional findings
+Locations (1)
| Facility | City | Country | Status |
|---|
| MUMC | Maastricht, Limburg | Netherlands | |
+Investigators
- Marco Das, Dr, Principal investigator, Maastricht University Medical Centre