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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04963127
Enrollment
800
Registered
2021-07-15
Start date
2021-07-15
Completion date
2025-05-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Edema, Fractures, Bone

Keywords

Spectral CT, Multi-Energy CT, Dual-Energy CT, Bone Marrow Edema

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.

Interventions

DIAGNOSTIC_TESTComputed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode

CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode

DIAGNOSTIC_TESTComputed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode

CT acquisition using a standard single energy / non-spectral acquisition mode

Sponsors

University Hospital Augsburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.MRI of the same region can be used for comparison if performed within 7 dayssensitivity, specificity and positive and negative likelihood ratios will be assessed

Countries

Germany

Contacts

Primary ContactSchwarz, MD
radiologie-studien@uk-augsburg.de+498214002441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026