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…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
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
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.
Study objective
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 design
Prospective study on FD-MRI and CT scan
With this amendment, we would like to include other hospitals to perform the
standardization of image quality using MRI phantoms and on three healthy
volunteers. Because of COVID restrictions, we cannot visit the centers
initially included (Hannover, Germany; and Sheffield, UK) in the projects.
To overcome this problem, we will include other hospitals in Netherlands with
similar MRI systems in order to perform the analysis on phantoms and 3
volunteers. Regarding the recruitment of volunteers, in light of the COVID-19
crisis and the complexity of the logistic, and to minimize the number of people
involved in the study, we aim to volunteer ourselves for the MRI scans: the PI
(P Ciet), the MRI physicist (P Wielopolski) and the PhD student (G Colzani).
Finally, a preliminary analysis of the data received from the center of
Hannover shows incomplete MRI data. To fulfill this data gap, we would like to
add the MRI data from a similar ongoing study in the hospital of Treviso, one
of our collaborating centers. The MRI protocol in this hospital is identical to
our MRI protocol and they are also using a different MRI system, which is the
same of that of Hannover. The study of Treviso has been approved by the local
IRB, and an amendment has been submitted to share the data with the Erasmus MC.
Study burden and risks
The burden for the healthy volunteers is minimal. Participation involves one or
two MRI-scans with a maximum duration of 60 minutes.
The healthy volunteers are members of the research team and have extensive
expertise in performing MRI-scans.
As for the patients in the center of Treviso there are no risks or extra burden
associated with participation in this study; they will only be asked to give
informed consent for the use of their MRI-scans for the VIPS-MRI study.
The results of this study have the potential to improve clinical understanding
and disease management. The new VIPS MRI protocol may improve detection and
quantification of structural and functional changes in the CF patients which
otherwise would not have been detected.
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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 |
|---|---|
| CCMO | NL64041.078.17 |
| Other | NL6618 (NTR6948) |