(1) to create and train an algorithm to generate synthetic CT images of the craniofacial area(2) to evaluate the resulting synthetic CT images in terms of geometrical accurate visualization of the craniofacial osseous structures compared to the…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Geometrical accuracy of the bone morphology by determining the mean surface
distance in mm between the cortical edges on synthetic CT and on true CT.
2. Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of
the radiodensity contrast.
3. Accuracy of the visibility of clinically relevant anatomical landmarks on
the synthetic CT images compared to the corresponding true CT images in the
adult population.
Secondary outcome
4. Evaluation of potential usefulness of the synthetic CT images for surgical
planning, surgical navigation and diagnostic purposes.
Background summary
In case of surgical procedures in the head and neck region, MRI in combination
with CT of the bone is often the standard modality to visualise bony landmarks
for planning, navigation and risk assessment. An important downside of a CT
scan is the associated radiation exposure, especially in children. An
additional downside is the sedation or general anaesthesia needed for both the
MRI- and CT-scan session in very young children. These downsides could be
removed if the CT scan can be substituted by an MRI sequence that can provide
the same information as CT.
This project aims to determine the feasibility of recreating CT like images of
the craniofacial bones from MRI images using machine learning techniques.
Study objective
(1) to create and train an algorithm to generate synthetic CT images of the
craniofacial area
(2) to evaluate the resulting synthetic CT images in terms of geometrical
accurate visualization of the craniofacial osseous structures compared to the
original CT by radiodensity reconstruction (technical validation)
(3) to evaluate the visibility of anatomical landmarks on the synthetic CT
images compared to the corresponding CT images in the adult population
(clinical validation).
Study design
prospective single-centre feasibility study
Study burden and risks
The burden and risks for the participating patients are comparable to standard
care. The CT scan is part of the necessary diagnostic work-up for these
patients. Although a slightly larger volume will be scanned for the purpose of
this study, the associated ionizing radiation dose will still be comparable to
standard care. For the purpose of this study, a short, dedicated MRI scan will
be obtained for each patient (research MRI). MRI scans are considered very low
risk procedures when appropriate guidelines are followed. Extra travel time and
lying still in the MRI machine will be the only burden for the patient. This
research MRI will be added to the electronic patient file (EPF), and as a small
potential benefit for the participant, screened for unexpected clinicically
relevant findings.Besides the acquisition of the research MRI, the subjects
will in no way be exposed to the synthetic CT images that will be generated by
the algorithm under development. The algorithm will not be used at the
investigation site and will not be part of the clinical workflow, nor will the
synthetic CT reconstructions be part of the patient*s file or decision-making
process of the healthcare professional.
Group benefit: If successful this study will bring an MRI-only workflow for
visualization of the temporal, facial bones and other skull-base structures one
step closer, by replacing CT scanning with MRI scanning in combination with the
synthetic CT algorithm. This would be especially beneficial for children during
their first years-of-life who need CT prior to cochlear implantation by taking
away the risks of radiation exposure.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Adults referred for a CT-scan of the mastoid, sinonasal complex or face.
Exclusion criteria
Pregnancy.
Contra-indications for MRI or CT.
Unwillingness to be informed about possible, clinically relevant, incidental
findings from the MRI examination.
Design
Recruitment
Medical products/devices used
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 | NL80426.029.22 |