Accuracy of Ultra-Low-Dose-CT of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort
Condition: Chest Pain; Cough; Thoracic Diseases; Lung Diseases
MeSH terms: Lung Diseases; Thoracic Diseases; Emergencies; Chest Pain
Study type: Interventional

Summary: 
      This trial compares the accuracy provided by plain film as well as
      ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences
      in diagnostic confidence and therapeutic consequence offered by these two imaging modalities.
    

Detailed description: 
      For nearly a century, chest X-ray (plain film, projectional radiography) has been the
      established primary imaging modality for patients with acute chest pain, suspected pneumonia,
      and / or acute dyspnoea in the diagnostic pathway of emergency departments, although the
      sensitivity and specificity of this X-ray technique are moderate.

      The widespread availability and use of chest X-ray is due to the low acquisition and
      operating costs for projectional radiography equipment, the short examination time, and the
      very low radiation exposure. In addition, projectional radiography of the chest often serves
      as a guide for further, more sensitive, diagnostical procedures. However, these advantages
      are partially offset by the disadvantages inherent to projectional methods: anatomical
      structures may superpose or mask pathological structures. As a result, some areas of the lung
      may be obscured, and assessment may therefore be limited.

      Whereas computed tomography was reserved for certain clinical questions over the last few
      decades, and, in most cases, served as a second imaging approach after plain film
      radiography, it has increasingly evolved as a primary imaging modality for several
      indications (e.g., suspicion of pulmonary embolism, highly suspected aortic dissection). This
      rise of computed tomography was due not only to its significant advantage of no
      superposition, but also partly driven by the marked reduction in radiation dose needed
      without sacrificing image quality. This was driven by the development of new detectors,
      modulation of tube current and voltage, as well as iterative reconstruction techniques. As a
      result, recent computed tomography scanners currently offer not only a more precise
      visualization of differences in tissue-attenuation and the significant advantage of the
      absence of artefacts due to superposition, but also allow for imaging with a considerably
      reduced radiation dosage compared to older scanners. Therefore, computed tomography may now
      be utilized as screening method in specific indications that carry an increased risk of
      certain pathologies (e.g., in long-time smokers). The introduction of the latest generation
      of computed tomography devices about three years ago allowed for an even further reduction in
      dose by filtering out low-energy photons using a tin filter, which offers the possibility of
      a reduction in radiation dose by another 50 % or more for established CT indications. For
      specific indications (e.g., lung nodules in follow-up), the radiation dose may even be
      reduced to a tenth or one-hundredth of a standard-dose CT (SDCT).

      The current reference dose-length-product (DLP) in Germany for thoracic standard-dose CT
      (SDCT) is ~350 mGycm (effective dose ~6 mSv) and, for thoracic low-dose-CT (LDCT / HR-CT),
      ~100 mGycm (effective dose ~1.7 mSv). However, the latest devices (third-generation
      dual-energy CT) provide the opportunity to considerably reduce the reference dose of thoracic
      low-dose CT. In the current literature, these scans are referred to as Ultra-Low-Dose-CT
      (ULDCT) and are usually associated with a radiation dosage of 0.14 to 0.5 mSv. For this dose
      range, no standardized reference values have been published as yet.

      The limiting factors of ULDCT are quantum noise, loss of spatial resolution, and other image
      artefacts. Therefore, careful selection of appropriate CT protocols and dosage is mandatory
      in order to achieve sufficient image quality to answer the respective diagnostic question.

      Several papers have been published on the subject of ULDCT, which are dedicated to the
      comparison of ULDCT with LDCT and/or SDCT. These papers conclude that this technology may be
      used with sufficient sensitivity and specificity for indications such as dyspnea, emphysema,
      or lung nodules. Due to the potential to reduce the radiation dose to less than 1/30 of a
      standard-dose CT while still providing acceptable image quality with the latest generation of
      devices, ULDCT of the chest is emerging as an interesting alternative to conventional chest
      X-ray.

      To the best of the authors' knowledge, there are currently no studies comparing and
      evaluating ultra-low-dose-CT as a primary imaging alternative to chest X-ray in emergency
      department patients.

      This study aims to compare ULDCT and plain film of the chest with regard to their accuracy in
      an unfiltered patient cohort of an emergency department. For this purpose, the investigator's
      ULDCT protocol will use the lowest possible dose at which image quality is diagnostically
      sufficient (approximately 0.2 mSv effective dose). This corresponds to less than 1/30 of the
      radiation dose of a standard-dose CT of the chest and to only about 2.5 times the dose of a
      chest X-ray in two views. This dose is equal to less than a month of natural background
      radiation in Austria and less than the radiation exposure on an intercontinental flight.

      In addition to the accuracy of ULDCT of the chest compared to plain film of the chest, this
      trial also aims to analyze the clinical relevance of both methods by assessing the respective
      impact on final diagnosis, as well as possible changes in therapy.
    

Intervention name(s): ULDCT
Intervention type(s): Diagnostic Test
Intervention description(s): Ultra-Low-Dose-CT (ULDCT) of the chest using tin filters with third-generation dual-energy CT devices. The projected dose used will be approximately 0.2 mSv per ULDCT of the chest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic