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van CCT (UK)

van CCT (UK)


- candidate number28246
- NTR NumberNTR6948
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2017
- Secondary IDs2018-002 MEC
- Public TitleVIPS-MRI
- Scientific TitleValidation of bi-dimensional (2D) and three dimensional (3D)Fourier Decomposition as Magnetic Resonance Imaging technique to assess lung ventilation and perfusion compared to computed tomography (CT) Hyperpolarised Gases and contrast enhanced MRI: a pilot study
- hypothesiswe 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
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteriaCF 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 criteriaAll
MRI contraindication (i.e. cardiac pacemaker, metallic implant, hearing aids, etc.)
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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jan-2019
- Target number of participants16
- InterventionsVIPS-MRI ( max 2x) and for healthy controls flow volume curve
- Primary outcomeTo 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
- Timepointsone visit
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Cystic Fibrosis Foundation
- Publications
- Brief summaryNovel 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.
- Main changes (audit trail)
- RECORD21-nov-2017 - 26-jan-2018

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