The primary objective is to identify and describe radiological tumor characteristics of glioma on 7 T MRI (possible relevant sequences: 3DT1, 3DT2, TOF, SWI (Duyn), FLAIR, spectroscopy and CEST) and 1.5/3 T MRI (relevant sequences: T1WI with and…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following radiological tumor characteristics will be assessed, if possible
within the 60 minutes MRI time, using the optimal imaging protocol of the 1.5/3
T MRI (T1WI with and without gadolinium, T2WI, FLAIR, SWI, perfusion(DSC), DWI)
and 7 T MRI (possible relevant sequences: 3DT1, 3DT2, TOF, SWI (Duyn), FLAIR,
spectroscopy and CEST).
We aim to investigate the feasibility of the following measurements:
With the 1.5/3 T MRI:
- Tumor boundaries
- Tumor vascularization
- Number and location of microbleeds
- Diffusion restriction
- Satellite lesions/multifocality of the tumor
- Susceptibility artifacts near tissue boundaries
- Magnetic field inhomogeneities )
- Tumorprogression compared to the previous MRI
- Pattern of contrast enhancing
With the 7 T MRI:
- Tumor boundaries
- Tumor vascularization
- Number and location of microbleeds
- Satellite lesions/multifocality of the tumor
- Susceptibility artifacts near tissue boundaries
- Magnetic field inhomogeneities (Signal dropout in certain brain regions)
- Metabolite information (spectroscopy: lactate, choline, lipids, myoinositol,
NAA)
Secondary outcome
- Duration of individual scans and the resolution needed
- Added value of each sequence in the diagnosis process
- Necessary protocol differences between operated and non-operated patients
- Robustness of sequences, especially also for providing good quality in
challenging regions (near cavities, operation zone, etc.)
- Characterization of tumor (pseudo)progression
Background summary
For better image quality, more and more stronger magnetic fields are used. An
MRI scanner with an extra high magnetic field, the 7 Tesla MRI, was installed
in the LUMC in 2007. So far, the additional value of the 7 Tesla MRI in
patients with glioma, compared to 1.5 or 3 Tesla MRI, is not known. The aim of
this research is to recognize radiological tumor characteristics, as well as
tumor and treatment response, with the 7 Tesla MRI and compare the results with
the 1.5 or 3 Tesla MRI. With this research the scanning methods can be further
improved and optimized. Our hypothesis is that in the MRI systems with a lower
field strength, the 7 Tesla-MRI has an additional role in identifying tumor
characteristics and in the future for evaluating tumor and treatment response.
Study objective
The primary objective is to identify and describe radiological tumor
characteristics of glioma on 7 T MRI (possible relevant sequences: 3DT1, 3DT2,
TOF, SWI (Duyn), FLAIR, spectroscopy and CEST) and 1.5/3 T MRI (relevant
sequences: T1WI with and without gadolinium, T2WI, FLAIR, SWI, perfusion (DSC),
DWI).
The secondary objective is to develop the most optimal scan protocol for
assessment of radiological tumor characteristics for diagnosis of glioma on 7
Tesla MRI.
Study design
The study *value of 7 Tesla in glioma* is a cross-sectional. All included
patients will have their regular follow-up MRI on 1.5/3 T MRI (including T1WI
with and without gadolinium, T2WI, FLAIR, SWI, perfusion(DSC), DWI) in
Haaglanden Medical Center (HMC), or Leiden University Medical Center (LUMC).
Within 4 weeks before or after this regular scan, a 7 T MRI in the LUMC
(possible relevant sequences include: 3DT1, 3DT2, TOF, SWI (Duyn), FLAIR,
spectroscopy and CEST) will be scheduled. The 7 Tesla MRI is performed without
any contrast agents and the MRI-scanning will be completed within 60 minutes.
Study burden and risks
It will cost the participants time to undergo the 7 Tesla MRIs. Nevertheless,
the subject will be in the 7 Tesla MRI for maximal 60 minutes and the 7Tesla
MRI will be performed without intravenously administered contrast agents. The
participant burden is believed not to be substantial.
The ultrahigh field MRI system is widely used in research setting and since its
first introduction in the 1990s no SAEs have been reported. Important temporary
side-effects are vertigo, nausea and involuntary eye motion due to forces on
ion currents in the semicircular loops. All individuals entering the 7 T MRI
are provided adequate sound protection to reduce the acoustic noise for
protecting the ears and increase patient comfort during MRI. Since magnetic
metal is attracted by the static field of the 7 T MRI a safety screening
questionnaire determines whether it is safe for the patient to have the MRI
(see list LUMC in attachment). The Investigational Medical Device Dossier
(IMDD) describes the risks analysis in more detail.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Highly suspected or histologically confirmed glioma
- Karnofsky performance status >= 70
Exclusion criteria
- Patients with a contra-indication for MRI (see list LUMC in attachment).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL65491.058.18 |