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

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 Overview

• Status: Recruiting
• Conditions: Fractures, Bone; Bone Marrow Edema
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Schwarz, MD; Phone Number: +498214002441; Email: radiologie-studien@uk-augsburg.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • University Hospital Augsburg
      • Contact: Florian Schwarz, MD; Phone Number: +498214002441; Email: radiologie-studien@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who are at least 18 years of age who are referred by the emergency department for a CT scan with the suspicion of a fracture.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Cohort; 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; CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode; Other Names: Spectral Imaging
Retrospective Cohort; 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; CT acquisition using a standard single energy / non-spectral acquisition mode

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Schwarz, MD, University Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Spectral CT; Multi-Energy CT; Dual-Energy CT; Bone Marrow Edema
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Edema
• Other Study ID Numbers: 21-0318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
• IPD Sharing Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• IPD Sharing Access Criteria: We plan to share data on request at this point in time.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No