Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema

Study Overview
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Brief Summary
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Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.

Official Title
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Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema

Conditions
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Fractures, Bone, Bone Marrow Edema

Intervention / Treatment
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* Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode
* Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical suspicion for a fracture AND indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND patient (is able to give informed consent and) has given informed consent. Exclusion Criteria: cardiorespiratory instability (as judged by the referring physician) age < 18 years known or suspected pregnancy known bone metastases of a malignant disease known rheumatic disease metal implants in the region to be scanned surgical intervention over the last 12 months in the region to be scanned contraindications for MRI

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 |
| --- | --- |
| Prospective Cohort<br>400 patients who are scheduled to undergo a clinically requested CT scan of parts of the skeleton using a Dual-Energy/Multi-Energy/Spectral acquisition mode to exclude or further define bone fractures. | Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode<br>* CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode<br>* Other names: Spectral Imaging;|
| Retrospective Cohort<br>400 patients who had undergone a clinically requested CT scan of the skeleton in standard acquisition mode in the past to exclude or further define bone fractures. | Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode<br>* CT acquisition using a standard single energy / non-spectral acquisition mode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard. | sensitivity, specificity and positive and negative likelihood ratios will be assessed | MRI of the same region can be used for comparison if performed within 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual-Energy CT, Bone Marrow Edema, Spectral CT, Multi-Energy CT