PneumoniaULTRACHESTNCT03140163
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
A study testing ULD-CT and CXR in people with Pneumonia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- ULD-CT and CXR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suffering from pneumonia and referred by their GP
Who cannot join
- Younger than 18
- Known pregnancy
- Not able to sign the Informed Consent document
- If not willing to be informed about additional findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- ULD-CT, CXR
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULD-CTRadiation
Also called Ultra Low Dose chest CT
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
CXRRadiation
Also called Conventional chest X ray
Conventional chest radiograph
| Study group | Role | What they receive |
|---|---|---|
| Subjects suffering from pneumonia | Experimental | CXR ULD-CT Receives: Radiation: ULD-CT; Radiation: CXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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
Measured: 2 year
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.
Measured: 2 year
Secondary outcomes (3)
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).
Measured: 2 years
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.
Measured: 2 year
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)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startSep 2016
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Das, Dr, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140163
- Sponsor's protocol ID
- METC161004
- Acronym
- ULTRACHEST
- Status last verified
- Nov 2018
- First submitted
- 16 Sep 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
- ClinicalTrials.gov ID
- NCT03140163
- Acronym / sponsor ID
- ULTRACHEST / METC161004
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects suffering from pneumonia | Experimental | Radiation: ULD-CT, Radiation: CXRCXR ULD-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suffering from pneumonia and referred by their GP
Key exclusion criteria (4 listed)
- Younger than 18
- Known pregnancy
- Not able to sign the Informed Consent document
- If not willing to be informed about additional findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULD-CTAlso: Ultra Low Dose chest CTSiemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT | Radiation | Subjects suffering from pneumonia |
| CXRAlso: Conventional chest X rayConventional chest radiograph | Radiation | Subjects suffering from pneumonia |
Primary outcome
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.
Time frame: 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
Time frame: 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
Time frame: 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.
3 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
Time frame: 2 years
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:
Time frame: 2 year
Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Das, Dr principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULD-CT and CXR in people with Pneumonia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.