Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT

Study Overview
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Brief Summary
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The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

Detailed Description
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The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants. This is a prospective, single-center, non-randomised, non-blinded trial with Tomosyntheis of Patients referred to the investigators institution to assess lung alterations and bone structure. All patients will undergo chest x-ray and tomosynthesis after informed consent. In addition they will undergo an ultralow-dose CT, wich is used as standart reference. The radiation dose of each method will be recorded. After completion of these three examinations, the participation in the study is completed.

Official Title
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Validation of Tomosynthesis for Indications for Clinical Questions Concerning Pathologies of the Chest and Skeletal Structures: When Can CT Been Omitted?

Conditions
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Lung Disease, Wrist Fracture

Intervention / Treatment
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* Other: Tomosythesis scan of the lung or the wrist
* Other: CT scan of the lung or the wrist
* Other: conventional X-ray of the lung or the wrist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for evaluation of lung-changes Patients scheduled for evaluation of the wrist after fracture or surgery Exclusion Criteria: general contraindications for x-Ray general contraindications for CT pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients scheduled for lung imaging<br>Patients with lung changes and scheduled for lung imaging will undergo: the scheduled conventional X-ray examination the scheduled CT scan the tomosynthesis scan | Other: Tomosythesis scan of the lung or the wrist<br>* All study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded.<br>Other: CT scan of the lung or the wrist<br>* All study participants will undergo CT imaging of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.<br>Other: conventional X-ray of the lung or the wrist<br>* All study participants will undergo conventional X-ray of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.<br>|
| Patients scheduled for wrist imaging<br>Patients with wrist fracture or with osteoprotetic material in the wrist and scheduled for wrist imaging will undergo: the scheduled conventional X-ray examination the scheduled CT scan the tomosynthesis scan | Other: Tomosythesis scan of the lung or the wrist<br>* All study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded.<br>Other: CT scan of the lung or the wrist<br>* All study participants will undergo CT imaging of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.<br>Other: conventional X-ray of the lung or the wrist<br>* All study participants will undergo conventional X-ray of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Inferiority CT | Value of Tomosynthesis-image information compared to CT | when scheduled for x-ray - 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority to x-ray | Value of Tomosynthesis-image information compared to x-ray | when scheduled for x-ray - 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteosynthetic implant, Tomosynthesis, CT, monitoring