Primary objective: to evaluate the image quality between the two protocols using Signal to Noise Ratio (SNR) measurements Secondary objectives: 1) test if measurements of lung volume and central airways dimensions using MRI are related to validated…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is to test an improved lung MRI protocol for
children. Our proposed protocol was first optimized in a group of adult
volunteers. We will assess the reliability of repeated measurements of lung
volume and central airways* dimensions using MRI in three groups of children
aged 8 -18 years old.
The main parameters assessed will be:
• Intra and inter-observer variability for multiple measurements of lung
volumes and central airways dimensions (i.e. cross-sectional areas) on MRI
• Absolute and relative differences in lung volumes and central airways*
dimensions computed by MRI, helium dilution, plethysmography and in the
CF group only, from the last CT scan performed in the 12 months prior to the
MRI.
• Correlations between lung function measurements related to volume (TLCbb,
TLChe, FVC; TLCbb-RV) and MRI and, in the CF patients only,
volumes from the previous CT as these values already exist and as an
additional assessment of the robustness of the lung volumes calculated
from these new sequences.
• Correlations between spirometry measurements related to central airway
dimensions (FEV1; PEF) and MRI central airway dimensions
• Correlations between lung function measurements related to small airways
disease (TLCbb-TLChe; RV, RV/TLC; FEF25-75, FEF75) and volume
of trapped air on MRI assessed by both the standard CF lung volume MRI
protocol and the new proposed MRI protocol
Secondary outcome
The secondary objectives of this study are:
• test if measurements of lung volume and central airways dimensions using
MRI are related to validated pulmonary function tests in children with
respiratory disorders and healthy controls;
• to assess the ability of a new MRI sequence protocol to detect TA.
Background summary
MRI offers a safe, radiation free imaging technique to evaluate structural lung
damage and improve our understanding of the pathophysiology of paediatric
asthma and cystic fibrosis (CF). Identification of early structural airway and
lung volume changes in both CF and asthma is needed to adjust treatment aimed
at preventing irreversible structural lung changes. Advances in MRI sequencing
protocols have improved the capacity of MRI to detect changes in lung
structure. We speculate that in CF and asthma, central airway dimensions may be
reduced due to airway wall thickening (AWT) and that the reduced lung volume
commonly reported in CF and may also be present in asthma patients. We
hypothesise that the new MRI protocol will be superior to the previous protocol
at calculating lung volumes and central airways dimensions, and subsequently
improve the detection and quantification of TA in both CF and asthma disease
pathologies.
Study objective
Primary objective: to evaluate the image quality between the two protocols
using Signal to Noise Ratio (SNR) measurements Secondary objectives:
1) test if measurements of lung volume and central airways dimensions using
MRI are related to validated pulmonary function tests in children with
respiratory disorders and healthy controls;
2) assess capacity to detect TA in a new MRI protocol
Study design
Single centre, cross-sectional hospital-based study
Study burden and risks
The burden associated with participation in this study is minimal. for CF
patients the MRI protocol is only 15 minutes longer than the routinely used
lung MRI protocol because additional improved sequences have been added. CF
patients are familiar with this MRI procedure as they routinely have a lung MRI
every second year as part of their annual examination. For CF patients, the
extra MRI will be scheduled in combination with a routine visit or with the
annual examination wherever possible. For asthmatic and healthy controls,
participation will involve an extra visit to the Sophia Children*s Hospital on
one occasion specifically for the study. Asthmatic children are used to lung
function measurements and some of them will have had an MRI.For the healthy
chidren everything will be new, maybe their sick brother /sister can support
them if needed.
An experienced lung function technician will guide the children during the
whole visit.
The primary benefits of participation in this study are that the new protocol
may improve detection and quantification of structural changes in the CF and
asthma patients which otherwise would not have been detected. There is no
direct benefit to healthy children participating in this study. Healthy
children are required as a control reference population to quantify lung volume
and airway dimensions using the new MRI sequences.
The only perceivable risk to the children in this study is that performing an
MRI may induce claustrophobia. This risk is negligible as all available methods
to familiarise the children and reduce this risk will have been implemented
prior to performing the MRI. If claustrophobia occurs, the child will be
withdrawn from the MRI machine immediately, and withdrawn from the study.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
•Age between 8 - 18 years;
• Clinical diagnosis of CF confirmed by a positive sweat test or two CF-related mutations OR
• Clinical diagnosis of asthma as confirmed by treating physician OR;
• Healthy child as determined by no history of respiratory disease or congenital deformities.
• Ability to perform lung function tests.
• Written informed consent from parents/caregivers
Exclusion criteria
•Inability to follow instructions of the investigator
•Claustrophobia
•Any clinical condition which, according to the treating physician, might put the patient at risk
•For CF patients: respiratory tract infection requiring IV antibiotics in the last 4 weeks
•For asthma patients: exacerbation requiring a course of oral corticosteroids in the last 4 weeks
any question answered with YES on the MRI questionnaire on contra indications
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 | NL47950.078.14 |
| Other | nummer aangevraagd |