Facilitation of translation of MR protocols from research to clinical setting.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Alle aandoeningen waarvoor een klinische indicatie voor MR onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of the additional MR acquisition methods may be evaluated for image
quality, may be compared with those of conventional MR techniques, and/or
results in clinical patients may be compared with the results (previously)
obtained in healthy volunteers. The additional MR acquisition methods could be
assessed for their incremental value, aspects for further optimization could be
identified and these could be incorporated in the continuing process of
development. Final step in this translation project is potential publication of
the results obtained by application of the additional MR protocols in clinical
patients. During this project more and better MR techniques and analysis tools
will become available for research purposes and patient care.
Main study parameters/endpoints will be described for each pilot study in an
addendum.
- Addendum 01 15/12/2015: myocardial triglyceride accumulation, native T1
relaxation times, ECV quantification, fibrosis/fat ratio.
- Addendum 02 06/11/2017: LIF score, fat fraction, T1 times, T2 times.
Secondary outcome
Not applicable
Background summary
Magnetic Resonance Imaging (MR) is continuously developing with a wide spectrum
of different (functional) contrasts, resulting in new applications each year.
These techniques are developed for both ultrahigh fields (7 Tesla) and clinical
field-strengths (1.5 and 3.0 Tesla), for advanced anatomical and functional
imaging, and for research purposes and daily clinical routine. The process of
development of these techniques includes phantom experiments and small pilot
studies in healthy volunteers (n<20).
However, the requirements of new MR techniques may differ when applied to the
healthy volunteer as compared to application in the clinical patient, for
example due to differences in subject biometrics and differences in imaging
conditions in research versus clinical setting. Also, selection of techniques
to be evaluated in clinical studies in such a setting is difficult, when only
normal volunteer data is available, Therefore, small pilot studies in the
patient group of interest are necessary to come to final optimization,
evaluation and validation of these MR protocols. Also, image processing and
analysis techniques of MR data derived from new acquisition protocols can only
be fully developed in case patient data is available, with pathology present
and/or with a wider range of physiological contrast. This enables optimization
of MR data analysis methods in its sensitivity and specificity for diagnosis of
the state of disease of interest.
Study objective
Facilitation of translation of MR protocols from research to clinical setting.
Study design
Observational. Patient inclusion implies extension of the clinical MR
examination by an additional MR protocol.
Details on study design will be specified for each pilot study in an addendum.
- Addendum 01 15/12/2015: 1H-MRS (proton magnetic resonance spectroscopy) and
native T1 mapping and extracellular volume (ECV) quantification in patients
diagnosed with/clinical suspicion of cardiomyopathy.
- Addendum 02 06/11/2017: non-lnvasive rapid assessment of patients with liver
transplants using Magnetic Resonance Imaging with LiverMultiScan
Study burden and risks
MR acquisitions will be added to the conventional clinical MR examination, with
a maximum prolongation of 15 minutes. None of the additional MR acquisitions
will involve additional injection of contrast agents or medication. If
applicable, invasive interventions such as overnight or morning fasting and /or
collection of blood samples will be motivated in an addendum.
- Addendum 01 15/12/2015: 6 hours fasting; blood sampling for interpretation of
MR data.
- Addendum 02 06/11/2017: 4 hourts fasting; no blood sampling.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Clinical indication for MR examination
Addendum 01 15/12/2015: diagnosis/clinical suspicion of cardiomyopathy
Addendum 02 06/11/2017: Patients over 18 years old with a liver transplant, due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation
Exclusion criteria
All contra-indications for MR examinations (claustrophobia, cardiac pacemaker, implants not approved for MR at the employed field-strength, metal objects, etc)
Incapable to undergo prolonged MR examination additonal to clinical MR examination (due to frailty of old age, general condition, ect).
No informed consent for notification of study participation to the medical specialist .
No informed consent for the work-up of incidental findings.;Addendum 01 15/12/2015: medical history of diabetes mellitus and/or medication use diabetes mellitus
Addendum 02 06/11/2017: any contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk bileleak, ascites etc)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL52871.058.15 |