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

NCT ID: NCT03140163

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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* 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

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Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects suffering from pneumonia

CXR ULD-CT

Group Type EXPERIMENTAL

ULD-CT

Intervention Type RADIATION

Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT

CXR

Intervention Type RADIATION

Conventional chest radiograph

Interventions

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ULD-CT

Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT

Intervention Type RADIATION

CXR

Conventional chest radiograph

Intervention Type RADIATION

Other Intervention Names

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Ultra Low Dose chest CT Conventional chest X ray

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Das, Dr

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

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MUMC

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METC161004

Identifier Type: -

Identifier Source: org_study_id

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