Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] (ULTRACHEST)
Primary Purpose
Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ULD-CT
CXR
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia
Eligibility Criteria
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
Sites / Locations
- MUMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects suffering from pneumonia
Arm Description
CXR ULD-CT
Outcomes
Primary Outcome Measures
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.
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
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
- 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 Outcome Measures
All 3 radiologist will be asked to write down on paper if they see an additional finding on either the ULD-CT or CXR
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:
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
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)
Full Information
NCT ID
NCT03140163
First Posted
September 16, 2016
Last Updated
November 16, 2018
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03140163
Brief Title
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
Acronym
ULTRACHEST
Official Title
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects suffering from pneumonia
Arm Type
Experimental
Arm Description
CXR ULD-CT
Intervention Type
Radiation
Intervention Name(s)
ULD-CT
Other Intervention Name(s)
Ultra Low Dose chest CT
Intervention Description
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
Intervention Type
Radiation
Intervention Name(s)
CXR
Other Intervention Name(s)
Conventional chest X ray
Intervention Description
Conventional chest radiograph
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
Title
Risk assessment of having a pneumonia for each subject
Description
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
Time Frame
2 year
Title
5 point likert scale to evaluate the "level of confidence" of each radiologist
Description
- 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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
All 3 radiologist will be asked to write down on paper if they see an additional finding on either the ULD-CT or CXR
Description
Three different thoracic radiologist will judge the scans and fill in a questionaire if they see any additional finding (Yes/No).
Time Frame
2 years
Title
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:
Description
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.
Time Frame
2 year
Title
Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires
Description
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)
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Das, Dr
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUMC
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
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