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

NCT03140163 | Unknown DMC

• 1 other identifier: METC161004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  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

  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:

  2 year

• Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires

  2 year

Study Arms (1)

Subjects suffering from pneumonia

EXPERIMENTAL

CXR ULD-CT

Radiation: ULD-CT; Radiation: CXR

Interventions

ULD-CT RADIATION

Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT

Also known as: Ultra Low Dose chest CT

Subjects suffering from pneumonia

CXR RADIATION

Conventional chest radiograph

Also known as: Conventional chest X ray

Subjects suffering from pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from pneumonia and referred by their GP

You may not qualify if:

• Younger than 18
• Known pregnancy
• Not able to sign the Informed Consent document
• If not willing to be informed about additional findings

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marco Das, Dr

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: May 4, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)