Validation of bi-dimensional (2D) and three-dimensional (3D) Fourier Decomposition (FD) as Magnetic Resonance Imaging (MRI) technique to assess lung ventilation and perfusion compared to computed tomography (CT), Hyperpolarised gases (HP-MRI) and Contrast-Enhanced MRI (CE-MRI)

Validation of bi-dimensional (2D) and three-dimensional (3D) Fourier Decomposition (FD) as Magnetic Resonance Imaging (MRI) technique to assess lung ventilation and perfusion compared to computed tomography (CT), Hyperpolarised gases (HP-MRI) and Contrast-Enhanced MRI (CE-MRI) - VIPS MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55881

Enrollment

Registered

2018-05-30

Start date

2019-04-30

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

cystic fibrosis

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: CF patients • Diagnosed with CF with sweat and genetic testing • Age between 10-18 years • Scheduled for biennial CT scan • Willing and capable to perform spirometer controlled chest MRI • Informed consent Healthy Volunteers • Age 10-18 years • Willing and capable to perform spirometer controlled chest MRI • Informed consent Healthy volunteers (MRI standardization) • Age 18 years and older • Willing and capable to perform chest MRI • Informed consent

Exclusion criteria

Exclusion criteria: All • MRI contraindication (i.e. cardiac pacemaker, metallic implant, hearing aids, etc.) • Claustrophobic • Pregnancy • Not willing or unable to perform MRI CF Patients • Recent (

Design outcomes

Primary

Measure	Time frame
• Amount of TA quantified on end-expiratory MR images expressed as % TA over the total lung volume • Ventilation defect (VD) on FD-MRI ventilation map expressed as % of total lung volume, • Amount of TA quantified on end-expiratory CT images (CF patients only) expressed as % TA over the total lung volume • PFT outcomes related to TA (FEF75, FEF25-75, and LCI).	—

Secondary

Measure	Time frame
Secondary study parameters will be used to assess image quality between the centres and reliability of the FD-MRI derives outcomes. • Image quality of each sequence between the centres expressed as: o SNR o T1, T2 and geometric distortion (GD) measurements o Spatial temporal resolution o Diffusion Weighted Imaging (DWI) measurements • Image quality on patients with CF and healthy volunteers will be assessed using a 5 point scale image quality score: 1. excellent image quality 2. mild peripheral airways blurring and motion artifacts 3. moderate peripheral airways blurring and motion artifacts 4. severe moderate peripheral airways blurring and motion artifacts 5. non diagnostic • Variability assessment for multiple measurements of image quality parameters on phantoms images between the centres will be tested with ICC or CCC analysis according data distribution. Also Bland-Altman plots will be used to assess systematic errors • Intra and inter-observer variability of semi-quantitative and quantitative FD-MRI derived parameters will be tested with ICC (or CCC) and Bland-Altman plots	—

Measure

Time frame

Secondary study parameters will be used to assess image quality between the centres and reliability of the FD-MRI derives outcomes. • Image quality of each sequence between the centres expressed as: o SNR o T1, T2 and geometric distortion (GD) measurements o Spatial temporal resolution o Diffusion Weighted Imaging (DWI) measurements • Image quality on patients with CF and healthy volunteers will be assessed using a 5 point scale image quality score: 1. excellent image quality 2. mild peripheral airways blurring and motion artifacts 3. moderate peripheral airways blurring and motion artifacts 4. severe moderate peripheral airways blurring and motion artifacts 5. non diagnostic • Variability assessment for multiple measurements of image quality parameters on phantoms images between the centres will be tested with ICC or CCC analysis according data distribution. Also Bland-Altman plots will be used to assess systematic errors • Intra and inter-observer variability of semi-quantitative and quantitative FD-MRI derived parameters will be tested with ICC (or CCC) and Bland-Altman plots

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Countries

Netherlands

Outcome results