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

NCT ID: NCT04963127

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2025-05-31

Brief Summary

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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

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Conditions

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Fractures, Bone Bone Marrow Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

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

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.

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Spectral Imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Augsburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Schwarz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Augsburg

Locations

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University Hospital Augsburg

Augsburg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Schwarz, MD

Role: CONTACT

[email protected]
+498214002441

Facility Contacts

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Florian Schwarz, MD

Role: primary

[email protected]
+498214002441

Other Identifiers

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21-0318

Identifier Type: -

Identifier Source: org_study_id