Dual-Energy Computed Tomography (DECT) in Acute Neck Infections: Comparison With Magnetic Resonance Imaging (MRI) (ANI-DECT)
Primary Purpose
Neck Abscess
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dual-energy CT
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Neck Abscess focused on measuring Computed tomography, Magnetic resonance imaging
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Suspicion of acute neck infection as deemed by the referring physician
Exclusion Criteria:
- History of a serious adverse reaction to intravenous iodine- or gadolinium-based contrast agent
- Severe kidney dysfunction (eGFR < 30 mL/min/1.73m2)
- Foreign metallic objects incompatible with MRI in the body
- Inability to give informed consent, as deemed by study physician
- Inability to follow study instructions
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DECT and MRI
Arm Description
Patients will be scanned with both DECT and MRI.
Outcomes
Primary Outcome Measures
Diagnostic accuracy
Diagnostic accuracy relative to clinical reference standard (clinical diagnosis or surgery)
Secondary Outcome Measures
Full Information
NCT ID
NCT05303922
First Posted
March 22, 2022
Last Updated
March 22, 2022
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05303922
Brief Title
Dual-Energy Computed Tomography (DECT) in Acute Neck Infections: Comparison With Magnetic Resonance Imaging (MRI)
Acronym
ANI-DECT
Official Title
Dual-Energy Computed Tomography (DECT) in Acute Neck Infections: Comparison With Magnetic Resonance Imaging (MRI) (ANI-DECT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this prospective study is to compare MRI and DECT in imaging acute neck infection. 50 patients suspected for neck infection will undergo both modalities, which will then be compared in terms of depiction of edema, conspicuity of inflammation, and characterization and number of abscesses. We hypothesize that DECT will have diagnostic performance comparable to that of MRI, and superior to that of traditional single-energy CT. This study will yield important new information about the performance of DECT, a novel and rapid method for emergency imaging.
Detailed Description
Deep neck infections present challenges even in modern medicine, due to complex anatomy and potentially lethal complications. True extent of the infection is difficult to assess clinically. Therefore, medical imaging is useful in determining the exact location and extent of disease. In suspected neck infection, computed tomography (CT) has traditionally been the first-line imaging method. However, magnetic resonance imaging (MRI) provides excellent soft-tissue characterization surpassing that of CT in the initial evaluation of neck infections. Previous studies have shown than MRI is superior to CT in terms of lesion conspicuity and number of affected spaces in neck infections. As an alternative to MRI, dual-energy CT (DECT) could offer improved soft tissue sensitivity compared with traditional single-energy CT. DECT refers to CT imaging carried out with two kinds of spectra of x-ray. In this prospective comparative study, we will recruit emergency patients with suspected neck infection. Neck MRI will be completed as part of standard clinical care, and DECT as part of this research study. After study completion, DECT and MRI will be compared by neuroradiologists, both modalities at separate occasions, blinded to the clinical information and diagnosis as well to the result of the other modality. Clinical care will be based on MRI as is usual practise. Surgical findings will be considered gold standard.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Abscess
Keywords
Computed tomography, Magnetic resonance imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each patient will be scanned with both DECT and MRI.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DECT and MRI
Arm Type
Experimental
Arm Description
Patients will be scanned with both DECT and MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual-energy CT
Intervention Description
Dual-energy CT
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
MRI
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Diagnostic accuracy relative to clinical reference standard (clinical diagnosis or surgery)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Suspicion of acute neck infection as deemed by the referring physician
Exclusion Criteria:
History of a serious adverse reaction to intravenous iodine- or gadolinium-based contrast agent
Severe kidney dysfunction (eGFR < 30 mL/min/1.73m2)
Foreign metallic objects incompatible with MRI in the body
Inability to give informed consent, as deemed by study physician
Inability to follow study instructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jussi Hirvonen, MD, PhD
Phone
+35823130000
Email
jussi.hirvonen@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussi Hirvonen, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi Hirvonen, MD, PhD
Phone
+35823130000
Email
jussi.hirvonen@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dual-Energy Computed Tomography (DECT) in Acute Neck Infections: Comparison With Magnetic Resonance Imaging (MRI)
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