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

Fractures, Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963127
• Other study ID #: 21-0318
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: University Hospital Augsburg
• Contact: Schwarz, MD
• Phone: +498214002441
• Email: radiologie-studien[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Edema
• Edema
• Fractures, Bone

Intervention

Diagnostic Test:
• Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode
CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode
• Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode
CT acquisition using a standard single energy / non-spectral acquisition mode

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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