Achieving reduction of the radiation dose, while optimizing and improving image quality using IMR in CT-scans of the cervical spine.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the current standard CT-scan and an additional
low-dose CT-scan with 40%, 60% or 80% lowered radiation dose. The main endpoint
is the subjective image quality at different radiation levels for iterative
reconstruction and model-based iterative reconstruction. The subjective image
quality, scored by two radiologists, will be leading in the acceptance of
low-dose CT images.
Secondary outcome
The secondary outcome measure is objective image quality at different radiation
levels for iterative reconstruction and model-based iterative reconstruction.
Hounsfield Units, noise, contrast-to-noise and signal-to-noise-ratios will be
used to determine objective image quality.
Background summary
Following the advice of (inter)national guidelines, we implemented computed
tomography (CT) as primary clearance tool in cervical spine trauma in our level
I trauma center in Zwolle, The Netherlands. Since then the prevalence of
fractures in cervical spine structures has more than doubled (increase of
110%). Along with a significant increase in fracture prevalence the mean
exposure in mSv also increased significantly (83.7%). New Iterative
Model-based Reconstruction algorithms like IMR (from Philips) are believed to
contribute to a possible reduction of radiation necessary for sufficient and
even improved image quality.
Study objective
Achieving reduction of the radiation dose, while optimizing and improving image
quality using IMR in CT-scans of the cervical spine.
Study design
This study will be a prospective single-centre diagnostic cross-sectional
cohort pilot-study. With the use of the NEXUS-criteria, trauma patients in need
of imaging of the cervical spine are identified. Written informed consent
will be requested before inclusion of the patient in the study. After written
consent, patients are randomly divided into three different groups and receive
a standard care CT at 100% radiation dose and an additional low dose CT scan
with 40%, 60% or 80% reduced radiation dose.
Study burden and risks
The patient does not have benefit from participating in this study and will
receive routine care. For research purposes an additional low-dose CT-scan is
obtained for each patient. The additional low-dose CT-scan will be analysed
after the study has been completed. We hypothesize that this study will
contribute to a lower radiation dose in future patients without compromising on
diagnostic accuracy.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Subjects >= 50 years old
- NEXUS-criteria positive
- Written informed consent.
Exclusion criteria
- Hemodynamically unstable (hypotension < 90 mmHg)
- (Glasgow Coma Scale) EMV score < 15
- Previous participation in the study
- Pregnancy
- Intoxication (e.g. Alcohol, Drugs)
- Concomitant participation in a study in which the patient is exposed to X-rays
- History of psychiatric disorder which causes the patient to be incompetent to make a thought-out decision.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61547.075.17 |