No registrations found.
ID
Source
Brief title
Health condition
High grade and low grade glioma
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify and describe radiological tumor characteristics of glioma on 7 Tesla MRI (3DT1, 3DT2, TOF,
FLAIR, T2*, MRS, CEST) and 1.5/3 T MRI (T1W1 with and without gadolinium, T2W1, FLAIR, perfusion (DSC), DWI).
Secondary outcome
To develop the most optimal scan protocol for assessment of radiological tumor characteristics of glioma
on 7 Tesla MRI.
Background summary
The 7 Tesla MRI is an ultrahigh field MRI system and shows great potential for the use in
clinical practice. In patients with glioma the 7 Tesla MRI may have an additional role in monitoring
treatment response and tumor progression, since at lower field MRI systems it is still difficult to
differentiate between radionecrosis and tumor recurrence. In different neurological diseases it has
already been proven that the 7 Tesla MRI provides additional information compared to lower field MRI
systems.
The primary aim of this study is to identify and describe radiological tumor characteristics in
glioma on 7 Tesla MRI compared to standard 1.5/3 Tesla MRI. The secondary aim is to develop an MRI
scan protocol for gliomas on 7 Tesla MRI.
The study "value of 7 Tesla in glioma" is across-sectional pilot study. For this pilot study
we aim to include 25 glioma patients.
The study population consists of adult patients with a histologically proven or
highly suspected glioma. With the standard imaging protocol of the 1.5/3 Tesla MRI (T1W1
with and without gadolinium, T2W1, FLAIR, perfusion(DSC), DWI) and a newly developed 7 Tesla
MRI scan protocol (3DT1, 3DT2, TOF, FLAIR T2*, MRS, CEST) we assess radiological tumor
characteristics and the effects of antitumor treatment.
Study objective
Compared to the lower field MR systems, 7 Tesla MRI has an additional role in
identifying tumor characteristics.
Study design
The work towards the secondary outcome objective is initiated at the start of the study. The development for the most optimal protocol is performed prior starting scanning patients and its feasibility is confirmed while the study is ongoing. For this, adjustments to the the 7T MRI image sequences are performed to obtain 1. high quality images, 2. a scanning protocol within reasonable time limits (60min).
The primary objective goal is reached after all patients have been included. However preliminary assessment of results will be done during inclusion. This study is also conducted at the 7T MRI, with the protocol resulting from the previous optimization step. The results obtained for this step will mostly result from medical/radiological expertise and visual evaluation.
Inclusion criteria
Age > 18 years old, highly suspected or histologically confirmed glioma and Karnofsky performance ≥ 70
Exclusion criteria
Patients with contra-indications for MRI
Design
Recruitment
IPD sharing statement
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 | NL9333 |
| Other | METC Leiden – Den Haag – Delft : P18.111 |