No registrations found.
ID
Source
Brief title
Health condition
Glioblastoma (GBM)
Sponsors and support
Intervention
Outcome measures
Primary outcome
MEG peritumoral BB power,
Radiological/Clinical progression
Secondary outcome
EEG peritumoral BB power,
CEST MRI,
rsfMRI,
questionnaires
Background summary
Rationale: Glioblastoma (GBM) growth and brain activity are intricately related, but it is unclear how exactly they co-evolve over time. More specifically, we hypothesize that GBM growth (as determined using routine magnetic resonance imaging (MRI) and clinical status) is preceded by increasing brain activity as operationalised with BB power and measured with magnetoencephalography (MEG) and/or electroencephalography (EEG, which might be a cheap and accessible alternative to MEG).
Objective: To investigate the relationship between MEG/EEG brain activity and GBM growth.
Study design: Longitudinal study.
Study population: 100 GBM patients
Main study parameters/endpoints: Main study parameters are (1) MEG/EEG brain activity at different timepoints during the disease, and (2) radiological and clinical markers of tumor growth. As secondary study parameters, we include (1) chemical exchange saturation transfer (CEST) MRI and resting-state functional MRI (rsfMRI) at a number of timepoints.
Study objective
- Hypothesis 1 (H1): MEG peritumoral broadband power is relatively stable in the context of stable disease and pseudoprogression in GBM patients.
- Hypothesis 2 (H2): MEG peritumoral broadband power increases significantly when progression occurs.
- Hypothesis 3 (H3): It is possible to create a cut-off for MEG peritumoral broadband power that yields adequate sensitivity and specificity in determining progression.
Secondary Objective(s):
- Repeat H1-H3 on EEG instead of MEG measures of peritumoral broadband power.
- Investigate the (added) value of chemical exchange saturation transfer (CEST), a protein-sensitive MRI technique that causes a frequency-encoded MR contrast, in determining progression. CEST shows promising initial results to delineate vital tumor without the use of exogenous gadolinium contrast, potentially even earlier than contrast depending methods.
- Investigate whether resting-state functional MRI (rsfMRI), an indirect measure of neuronal activity, may also pertain to GBM progression.
Study design
Maximum 5 time points per subject
Intervention
None
Inclusion criteria
(1) age > 17 years
(2) histopathologically confirmed GBM
(3) eligible to start the standard treatment of concomitant chemoradiation followed by adjuvant chemotherapy
Exclusion criteria
(1) psychiatric disease or symptoms at the time of inclusion
(2) other comorbidities of the central nervous system, particularly cerebrovascular accidents, multiple sclerosis, Alzheimer’s disease at the time of inclusion
(3) insufficient mastery of the Dutch language,
(4) inability to communicate adequately.
For undergoing the secondary endpoint of additional MRI measurement, patients are excluded when they have contraindications for MRI, but will still be included for the primary endpoints of MEG/EEG and tumor progression.
Design
Recruitment
IPD sharing statement
Plan description
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 | NL9817 |
| Other | METC VUmc : METC 2021.0187 |