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

Recruiting

• Conditions: Fractures, Bone; Bone Marrow Edema
• Interventions: 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

• Registration Number: NCT04963127
• Lead Sponsor: University Hospital Augsburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study Start: 2021-07-15
• Study First Posted: 2021-07-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode	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.
Retrospective Cohort	Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode	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.

Primary Outcome Measures

Name	Time	Method
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 days	sensitivity, specificity and positive and negative likelihood ratios will be assessed

Trial Locations

Locations (1)

University Hospital Augsburg; 🇩🇪 Augsburg, Bavaria, Germany