Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] (ULTRACHEST)

November 16, 2018 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • MUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects suffering from pneumonia
CXR ULD-CT
Radiation: ULD-CT
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
Other Names:
  • Ultra Low Dose chest CT
Radiation: CXR
Conventional chest radiograph
Other Names:
  • Conventional chest X ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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
2 year
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.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three different thoracic radiologist will judge the scans and fill in a questionaire if they see any additional finding (Yes/No).
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

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.
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

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)
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Marco Das, Dr, Maastricht University Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC161004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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