Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
Time Frame: MRI of the same region can be used for comparison if performed within 7 days
sensitivity, specificity and positive and negative likelihood ratios will be assessed
Secondary Outcomes
No secondary outcomes reported