NCT05303922

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

March 22, 2022

Last Update Submit

March 22, 2022

Conditions

Neck Abscess

Keywords

Computed tomographyMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Diagnostic accuracy relative to clinical reference standard (clinical diagnosis or surgery)

    1 day

Study Arms (1)

DECT and MRI

EXPERIMENTAL

Patients will be scanned with both DECT and MRI.

Diagnostic Test: Dual-energy CTDiagnostic Test: MRI

Interventions

Dual-energy CTDIAGNOSTIC_TEST

Dual-energy CT

DECT and MRI
MRIDIAGNOSTIC_TEST

MRI

DECT and MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Suspicion of acute neck infection as deemed by the referring physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

RECRUITING

Study Officials

  • Jussi Hirvonen, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Hirvonen, MD, PhD

CONTACT

+35823130000jussi.hirvonen@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Each patient will be scanned with both DECT and MRI.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

March 22, 2022

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)