Lung MR in children

Central airways and lung volume assessment by Magnetic Resonance Imaging (MRI) in children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22658

Enrollment

Registered

2014-01-22

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

cystic fibrosis, astma

Interventions

MRI and lung function tests

Eligibility

Inclusion criteria

Inclusion criteria: • Aged 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 parent

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

Design outcomes

Primary

Measure	Time frame
• Signal to Noise Ratio (SNR) between the current clinical protocol (MRI1) and the proposed protocol (MRI2) • Intra and inter-observer variability for multiple measurements of lung volumes, central airways’ dimensions (i.e. cross-sectional areas) on MRI	—

Secondary

Measure	Time frame
• 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 CT scan performed 12 months prior to the MRI. • Correlation of lung function measurements related to volume (FVC, TLCbb, TLChe, TLCbb-TLChe/TLCbb, RV/TLC), central airway diameter and/or cross-sectional areas (FEV1, PEF) and small airways disease (FEF25-75) with those assessed by MRI and CT (only applicable to CF patients) • 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

• 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 CT scan performed 12 months prior to the MRI. • Correlation of lung function measurements related to volume (FVC, TLCbb, TLChe, TLCbb-TLChe/TLCbb, RV/TLC), central airway diameter and/or cross-sectional areas (FEV1, PEF) and small airways disease (FEF25-75) with those assessed by MRI and CT (only applicable to CF patients) • 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

—

Contacts

Public ContactE. Wiel van der

Erasmus MC - Sophia Children’s Hospital Room Sb2778 Wytemaweg 80

e.vanderwiel@erasmusmc.nl+31(0)10 4636797

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)