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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Pneumonia

Treatments: Radiation: CXR; Radiation: ULD-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03140163

METC161004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Subjects suffering from pneumonia

Experimental group

Description:

CXR ULD-CT

Treatment:

Radiation: ULD-CT

Radiation: CXR