To characterize glioma and epileptogenic tissue with 7T metabolic MRI, and validate their metabolic imaging characteristics with histopathological measures.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Metabolic imaging measures of different molecules of interest in glioma tissue
(including but not limited to: N-acetylaspartate (NAA), choline, creatine, 2HG
and cystathionine) and epileptogenic tissue (including but not limited to
glutamate, gamma-aminobutyric acid (GABA) and iron) as acquired with 7T
metabolic MRI.
Secondary outcome
Comparison of the metabolic imaging measures of different molecules of interest
with histopathological measures.
Background summary
Conventional MRI has been established as one of the main pillars of
neuroimaging. However, for several neurological diseases, it can be relatively
limited in detecting or delineating pathological tissue (e.g. MRI negative
epilepsy and disease spread in glioma), and it is usually not specific enough
to provide a definitive diagnosis with the same certainty as histopathological
analysis (e.g. tumor progression versus radiation necrosis and relevant
molecular subtypes of low grade glioma). Metabolic MRI - visualizing the
metabolic *phenotype* of diseases - can improve diagnostic
specificity whereas ultrahigh magnetic field strengths (7T) can improve
diagnostic sensitivity as well as boost the diagnostic specificity of metabolic
MRI. The goal of this study is therefore to acquire multiple metabolic imaging
characteristics with 7T (metabolic) MRI of two common neurological diseases
that are diagnostically limited by conventional MRI and receive surgical
treatment (glioma and epilepsy), thus allowing for validation of the
metabolic phenotype with the true molecular phenotype defined by histopathology
to eventually use the acquired metabolic imaging characteristics in the
clinical diagnostic process.
Study objective
To characterize glioma and epileptogenic tissue with 7T metabolic MRI, and
validate their metabolic imaging characteristics with histopathological
measures.
Study design
An observational non-therapeutic cohort study with two cohorts.
Study burden and risks
MRI is an invasive imaging modality, involving high magnetic fields, which to
the best of our knowledge is not associated with short or long-term adverse
effects. Potential burdens are loud acoustic scanner noise and slight
discomfort (dizziness) that may occur due to peripheral nerve stimulation.
Subjects with glioma-associated epilepsy will receive intravenous contrast
administration, which is a minimal invasive procedure with minor risks not
different to when applied in clinical practice. Application of the infusion may
be painful. Participating patients will not benefit from the results of this
study. However, future patients may benefit as this study could lead to better
understanding of glioma and epilepsy physiology, improving diagnosis and
treatment evaluation with consequent treatment decisions. Furthermore, it may
lead to the discovery of new (molecule-based) treatment options.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Aged 16 years or over and able to exercise their free will (capacitated);
• Diagnosed with glioma-associated epilepsy or focal epilepsy with a relevant
lesion on conventional MRI or PET;
• Scheduled for surgical treatment;
• Informed and having given informed consent
Exclusion criteria
• The presence of claustrophobia;
• MRI-specific exclusion criteria, such as metallic implants and pregnancy;
• Refusal or inability to provide informed consent.
Design
Recruitment
Medical products/devices used
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 | NL74932.041.20 |