To investigate whether proton MRI can be used to visualize disease and to study lung mechanics. This new information might give us new insights into the pathophysiology of asthma.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ventilation defect expressed as percentage of total lung volume on an oxygen
enhanced MRI map and area of low intensity regions on end-expiratory magnetic
resonance images.
Secondary outcome
Secondary study parameters will be used to investigate whether proton MRI can
be used to detect ventilation, perfusion and structural pulmonary abnormalities
in paediatric asthma population.
- Total lung volume (ml)
- Normal lung tissue, expressed as % of total lung volume
- Structural abnormalities: presence of airway wall thickening, mucus plugging,
consolidations, atelectasis, etc.
- Perfusion: areas of low intensity regions, expressed as % of the total lung
volume and on Fourier decomposition sequences showing a ventilation/perfusion
map, with areas of perfusion defect, expressed as a % of total lung volume maps
- Changes in percentage of LIR on end-expiratory MR images and VD on OE-MR will
be compared before and after bronchodilation. The aim of this comparison is to
determine whether these defects are affected by smooth muscle relaxation.
- Lung function parameters obtained from:
- Spirometry (FEV1, FVC, FEV1/FVC, FEF25-75 and FEF75)
- Multiple breath washout (Lung clearance index)
- Oscillometry at 5-11-19Hz (Rinsp, Rexp, Rtot, Xinsp, Xexp, Xtot)
Background summary
Structural and functional alterations of the small airways in patients with
asthma are frequently observed. Small airways disease (SAD) is present in
approximately 50-60% of patients with asthma. Small airways disease is
associated with uncontrolled asthma and future loss of asthma control. It is
therefore important to detect and monitor SAD. Over the past years imaging
methods have been developed to gain knowledge on structure and function of the
(small) airways in the lung. Magnetic resonance imaging (MRI) is a radiation
free imaging modality that can provide both information on lung structure and
function in a single examination. The advantage of MRI is that it is non
ionizing and non-invasive diagnostic tool and therefore suitable to be
performed longitudinally. There are some technical challenges related to MRI in
patients with pulmonary disease: low/weak proton density of lung tissue, long
scanning times and motion artefacts. These artefacts are more prominent in
children due to their inability to lay still for a long time and their high
respiratory and cardiac rate. As a solution to the low proton density
hyperpolarising gases were introduced as contrast agent. However, the use of
polarised gases has several downsides: polarised gases are expensive,
polarisation of these gases is complicated and special training of personnel is
needed to perform MRI with hyperpolarized gases. New MRI protocols, using
proton MRI sequences, were developed to overcome the challenges in MRI imaging
of pulmonary diseases without the use of hyperpolarized gases. In adults these
MRI techniques have been shown to correlate well with computed tomography and
polarizing gases MRI. Proton MRI might therefore be a novel diagnostic tool to
assess small airways disease in asthma and evaluate effect of treatment. This
is especially important for the paediatric population as it potentially could
replace chest computed tomography that requires ionizing radiation.
Study objective
To investigate whether proton MRI can be used to visualize disease and to study
lung mechanics. This new information might give us new insights into the
pathophysiology of asthma.
Study design
This is a prospective cross-sectional feasibility MRI study that will be
conducted at the Erasmus MC - Sophia Children*s Hospital.
Study burden and risks
The only perceivable risk to the children in this study is that performing an
MRI may induce claustrophobia. All available methods to familiarize the
children and reduce this risk will be applied prior to the MRI. If
claustrophophia occurs, the child will be withdrawn from the MRI machine
immediately, and withdrawn from the study. The data derived from this study has
the potential to improve our understanding of the pathophysiology of asthma in
children which can be helpful to personalize therapy. Furthermore, if it turns
out that proton MRI can be used in the paediatric population to assess small
airway disease and ventilation abnormalities in asthma than this might be used
as a tool to assess asthma control and the effect of treatment. Furthermore
this study may improve the mechanical understanding of the underlying
mechanisms that cause asthma.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Asthma patients:
- Age 6-18 years
- Diagnosis of asthma for at least 6 months, in accordance with a paediatric
pulmonologist
- Small airways obstruction as assessed by pulmonary function testing, defined
as:
- Dissociation between FVC and FEF75 values: FEF75 at least 30%
(absolute % predicted) below FVC.
- FVC within normal limits (for this study defined as FVC >= 80%
predicted)
- Ability and will to perform spirometer controlled chest MRI
- Ability and will to provide written informed consent
Healthy Volunteers:
- Age 6-18 years
- Siblings or friend of the asthma patients
- No known pulmonary disease
- Ability and will to perform spirometer controlled chest MRI
- Ability and will to provide written informed consent
Exclusion criteria
- MRI contraindication (cardiac pacemaker, metallic implant, hearing aids,etc.)
- Self-reported pregnancy
- Claustrophobia
- Use of SABA (e.g. albuterol or salbutamol) as escape medication <8 hours ago
- Use of LABA (e.g. formoterol or salmeterol) medication <48 hours ago
- Inability to follow instructions of the investigator
- Inability or not willing to perform spirometer controlled chest MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL77524.078.21 |
Other | NL9513 |