No registrations found.
ID
Source
Brief title
Health condition
cystic fibrosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
To validate 2D and 3D FD as technique to assess lung ventilation compared to CT and PFT outcomes related to lung ventilation.
Secondary outcome
• To develop and standardize the VIPS MRI platform
• To develop semi-quantitative and quantitative image analysis methods for the most clinical relevant VIPS outcome measures including outcome measures derived from fused images
Background summary
Novel promising MRI sequences have been developed that are possibly sufficiently sensitive to allow monitoring of structural abnormalities(12). In addition, MRI sequences have been developed that possible allow non-invasive monitoring of perfusion and ventilation(13). Finally, MRI sequences have been developed to detect lung inflammation, which could allow the monitoring of lung inflammation without the need for PET-CT or PET-MRI(14).
However, before these novel MRI sequences can be utilized routinely, to improve our monitoring options for CFLD on a wider scale, they have to be integrated into a patient-friendly time-efficient protocol that can be standardized across centers for the major MRI vendors (GE, Philips, Siemens). In addition, some further validation of these novel sequences is needed.
In 2014 we formed the ventilation, inflammation, perfusion and structure (VIPS-MRI) consortium with the ambition to jointly develop a VIPS-MRI platform that could be used across MRI vendors. The VIPS-MRI consortium includes the following centers: Erasmus MC (EMC), Rotterdam, Netherlands; Medizinische Hochschule Hannover (MHH), Hannover, Germany; Royal Hallamshire Hospital Sheffield (RHHS), Sheffield, UK and Princess Margaret Hospital (PMH), Perth, Australia.
Objective of the study
The final goal of this validation plan is to develop an MRI platform that can provide information about ventilation, inflammation, perfusion and structure (VIPS-MRI) in a single MRI examination of 30 minutes for safe and efficient monitoring of CFLD.
Study objective
we hypothesize that VIPS-MRI can be developed into a patient friendly time efficient MRI to measure ventilation inflammation perfusion and structure without the use of medical gases or contrast
Study design
one visit
Intervention
VIPS-MRI ( max 2x) and for healthy controls flow volume curve
H Tiddens
wytemaweg 60
Rotterdam 3015 CN
The Netherlands
010 7036263
h.tiddens@erasmusmc.nl
H Tiddens
wytemaweg 60
Rotterdam 3015 CN
The Netherlands
010 7036263
h.tiddens@erasmusmc.nl
Inclusion criteria
CF patients
• Diagnosed with CF with sweat and genetic testing
• Age years 12-18 years
• Scheduled for biennial CT scan
• Willing and capable to perform spirometer controlled chest MRI
• Informed consent
Healthy Volunteers
• Siblings or friends of the CF participants
• Age 12-18 years (age and gender matched to CF patients)
• Willing and capable to perform spirometer controlled chest MRI
• Informed consent
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 (< 1 month) RTE with use of i.v. antibiotics
• Chronic oxygen therapy
• Any other severe comorbidities that could limit imaging
Healthy volunteers
• Recent (< 1 month) history of lung disease (i.e. pneumonia)
• Known history of chronic lung disease (i.e. asthma)
• Known history of congenital lung disease (i.e. bronchopulmonary dysplasia, tracheomalacia)
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 |
|---|---|
| NTR-new | NL6618 |
| NTR-old | NTR6948 |
| Other | MEC : 2018-002 |