central airways and lung volume assessment by Magnetic Resonance Imaging in children

central airways and lung volume assessment by Magnetic Resonance Imaging in children - lung MR protocol in children

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41163

Enrollment

Registered

2014-07-30

Start date

2015-02-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

astma cystic fibrosis

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results