ung MR in childre
- Conditions
- cystic fibrosis, astma
- Registration Number
- NL-OMON22658
- Lead Sponsor
- erasmus Mc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
• 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
• 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Signal to Noise Ratio (SNR) between the current clinical protocol (MRI1) and the proposed protocol (MRI2)<br>• Intra and inter-observer variability for multiple measurements of lung volumes, central airways’ dimensions (i.e. cross-sectional areas) on MRI<br>
- Secondary Outcome Measures
Name Time Method • 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.<br>• 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)<br>• 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<br>