About this trial
MR pulse for whole brain optimal Deuterium (2H) Metabolic Imaging and EPSI (echo planar spectroscopic imaging) based SLOW-edited 1H-MRSI will be developed and optimized for use at an UHF scanner at 7 Tesla. The study has 4 phases.
Phase I: The 2H and 1H MRSI sequences are developed and optimized in vitro (phantoms)
Phase II: Sequences are applied in vivo in healthy volunteers and further optimized
Phase III: Optimal 2H 1H pulse sequences are applied in 4 cohorts of healthy volunteers, to study the effect of aging with whole brain 2H and 1H MRSI.
Phase IV: application of the sequences in 4 patient groups with different diseases: Alzheimer's diseases (AD) patients, diabetes mellitus type II (DM) patients, mild cognitive impaired (MCI) patients, and high grade carotid stenosis patients (HGCS).
The ultimate aim is to create for individual patient specific 3dimensional spatial resolved z-score maps (similar to FDG-PET) based on the healthy control data of phase III of the trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed informed consent by the participant.
Ability to lie still in the MR scanner for at least one hour.
No current or lifetime history of drug or alcohol abuse.
No medications that interfere with cognition.
Disqualifiers
Under 18 years of age.
Claustrophobia.
Pregnancy or current state of lactation.
Active implants (e.g., pacemakers, neuro-stimulators).
Trial design
Sequential
Treatments tested in this trial
Application of new pulse sequence package SIGNATURES2023 to healthy controls
DeviceOne or more novel or further optimized non CE-marked pulse MRSI sequence is/are applied to 100 healthy subjects to determined reference metabolite maps of the whole brain
Application of new pulse sequence package SIGNATURES2023 to 4 groups of patients (pilot)
DeviceOne or more novel or further optimized non CE-marked pulse MRSI sequence is/are applied to 4 time 10 patients with AD, MCI, DM and HGCS to determine metabolite maps of the whole brain.
Treatment groups
Trial outcomes
Primary outcomes
3D spatial resolved Deuterium metabolite imaging (DMI)
Coregistered deuterium metabolite distributions (glucose, glutamate) is measured in a young healthy control group of 20 person (\<40 years) is obtained, as well as coregistered deuterium metabolic images of metabolite distribution in a elder healthy control group of 20 person (\>40 years) is obtained.
3D spatial resolved SLOW-EPSI MRSI metabolite mapping
Coregistered neuro-metabolite distributions (e.g. GABA, glutamate) distribution in a young healthy control group of 20 persons (age \< 40 years) are measured, as well as coregistered neuro-metabolite distributions (e.g. GABA, glutamate, ..) are measured in healthy control group of 20 persons (age \> 40 years).
3D spatial resolved 3D DMI and 3D SLOW-EPSI MRSI mapping in Alzheimer's disease (AD) patient group
Coregistered DMI (glucose, glutamate) maps and neuro-metabolite images (e.g. GABA, glutamate, ..) distribution in an Alzheimer's disease (AD) patient group of 10 persons are obtained.
3D spatial resolved 3D DMI and 3D SLOW-EPSI MRSI mapping in Mild Cognitive Impairment (MCI) patient group
Coregistered DMI (glucose, glutamate) maps and neuro-metabolite images (e.g. GABA, glutamate, ..) distribution in a Mild Cognitive Impairment (MCI) patient group of 10 persons are obtained.
Sponsors and contacts
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