Primary Aim: to validate 3D Spiro MRI against PCD-CT for accurate phenotyping and sensitive monitoring of children with CPPD, by assessing disease severity in term of regional lung structural and functional changes compared to PCD-CT.Secondary aim(s…
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is to investigate whether 3D Spiro MRI can be used
to assess CCPD compared to PCD-CT:
N=90 Research MRIs - PRIME score
N=90 Clinical PCD-CTs - PRAGMA score
PRAGMA score quantifies lung abnormalities in a hierarchical order, with
results expressed as % of total lung volume.
PRIME score is an adapted version of the PRAGMA score, for the MRI scan.
Secondary outcome
To address the secondary aims, the following secondary study parameters will be
collected:
• PFTs outcomes
o Spirometry (FEV1, FVC, FEV1/FVC, FEF25-75 and FEF75)
o Multiple breath washout (Lung clearance index)
o Oscillometry at 5-11-19Hz
• Research questionnaires data
• N=90 Research MRIs - 3D Spiro MRI biomarkers (17), PREFUL MRI outcomes (21)
• N=90 Clinical PCD-CTs - BronchusArtery (BA) ratios, Ventilation estimation
from registered analysis (VERA) analysis scores, Pulmonary Artery and Vein
analysis outcomes
Background summary
Chronic pediatric pulmonary diseases (CPPD) include a large range of pulmonary
diseases, such as cystic fibrosis (CF), bronchopulmonary dysplasia (BPD) and
asthma. These diseases have a significant impact on patient*s quality of life
and survival. Recent development of the Photon counting detector CT (PCD-CT)
opens up new possibilities to significantly reduce radiation dose without
reduction of image quality. Secondly, a recently developed magnetic resonance
imaging (MRI) techniques provide new insight in pulmonary diseases. 3D MRI
spirometry is a new MRI technique that combine structural and functional
information in a single examination as radiation-free alternative to chest CT.
There is a need of new safe and precise objective measure to monitor CPPD.
Study objective
Primary Aim: to validate 3D Spiro MRI against PCD-CT for accurate phenotyping
and sensitive monitoring of children with CPPD, by assessing disease severity
in term of regional lung structural and functional changes compared to PCD-CT.
Secondary aim(s): to assess a) the regional lung mechanics with respect to
disease severity and establish reference flow-volume loop maps using 3D Spiro
MRI; b) chest-CT protocol improvement for monitoring CF and BPD patients in
term of resolution, dose, and disease quantification using the new PCD-CT
technology compared to historical CF, BPD and asthma cohorts; c) to define
sensitivity of 3D Spiro MRI compared to PCD-CT, Pulmonary Function Tests (PFTs)
and Quality of life (QoL) questionnaires to quantify structural and functional
changes in the CF, BPD and asthma cohorts; d) the relation between ventilation
MRI parameters derived from 3D Spiro MRI with ventilation parameters obtained
from PREFUL MRI and low intensity region (LIR) and low attenuation region (LAR)
quantified from expiratory MRI and CT and PFT (LCI) and e) how children with
CPPD and their caregivers experience the two procedures, and whether and how it
affects their understanding, imagination and feelings of their body and
disease.
Study design
Prospective and retrospective study
Study burden and risks
This study includes one visit to the hospital for the patients. The patients
are routinely referred for a CT scan in order to monitor disease progression as
part of current follow-up scheme for CF and BPD patients. For asthma patients,
CT is usually indicated when not responding to treatment to exclude other cause
of pulmonary symptoms. The additional MRI scan will require a longer stay at
the hospital for examination, but will not contribute to any additional
radiation exposure. MRI protocol will not include the use of any contrast. Due
to the choice to include children above the age 5, no anaesthesia will be
required.
MRI scanners are rather loud operating machines; therefore a child might feel
scared to undergo the scanning procedure. However, standard operating
procedure and demonstration video are already in use to make the entire MRI
experience less cumbersome. The study interventions also will include health
status questionnaires and interview with researcher(s) to describe experience
with both MRI and CT technique.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
CF Cohort
• children aged 5 to 18 years
• CF patients referred for an annual follow-up
BPD Cohort
• children aged 5 to 18 years
• BPD patients referred for follow-up
Asthma Cohort
• children aged 5 to 18 years
• Difficult-to-treat asthma children referred for CT examination
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Children diagnosed with CF, difficult to treat asthma or BPD under the age of
5
• Pulmonary exacerbation (CF and Asthma)
• Claustrophobia
• Inability to perform the breathing manoeuvres
• Any contraindication(s) to undergo 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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85470.078.23 |