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NCT06705010

Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

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.

Official title: Non-Invasive Monitoring of Brain Metabolites Using Novel and Adapted Proton and Deuterium MR Techniques

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-04-01

Completion Date

2028-03-31

Last Updated

2025-03-25

Healthy Volunteers

Yes

Conditions

Aging Brain Metabolic Disorder Carotid Stenosis Alzheimer Disease Diabetes Type 2 Mild Cognitive Impairment Brain Disease

Interventions

DEVICE

Application of new pulse sequence package SIGNATURES2023 to healthy controls

One 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

DEVICE

Application of new pulse sequence package SIGNATURES2023 to 4 groups of patients (pilot)

One 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.

General Inclusion Criteria (applicable to all groups): 1. Signed informed consent by the participant. 2. Ability to lie still in the MR scanner for at least one hour. 3. No current or lifetime history of drug or alcohol abuse. 4. No medications that interfere with cognition. 5. Normal or corrected-to-normal vision. Disease-Specific Inclusion Criteria: I. Type 2 Diabetes Patients group (PG-IV-2H-DM): * Diagnosis of Type 2 diabetes according to the ADA classification. * Treatment with lifestyle modification and/or non-insulin agents. II. High-Grade Carotid Stenosis Patient Group (PG-IV-1H-HGCS): * ≥50% stenosis of the carotid artery. III. Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (PG-IV-2H-AD/MCI): * Diagnosis of Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD). * Age range between 60-80 years. * Fluent in German. * Normal or corrected-to-normal vision and hearing. * Ability to understand the research and provide informed consent. Exclusion Criteria: 1. Under 18 years of age. 2. Claustrophobia. 3. Pregnancy or current state of lactation. 4. Active implants (e.g., pacemakers, neuro-stimulators). 5. Passive ferromagnetic implants. 6. Passive non-ferromagnetic metallic implants \> 4 cm in a region covered by the active radio frequency (RF) coils. 7. Large tattoos inside a region covered by the active RF coils. 8. Known or suspected non-compliance. 9. Underweight \<30 kg body weight. 10. Body mass index (BMI) \> 30. 11. Overweight \>135 kg 12. Persons with extreme big head circumference or extreme astigmatism, which cannot be corrected by MR-compatible eyeglasses. 13. Persons not able to understand the informed consent form. 14. Not agreeing with the institute's policy to inform the subject on incidental findings discovered during the examination. 15. Visual and auditory acuity impairing neuropsychological testing (if relevant). 16. Diabetes or glucose intolerance according to WHO recommendations (excluded in the diabetes patient group). 17. Evidence of overt heart or renal disease. 18. Evidence of gastrointestinal tract disease. 19. Cognitive impairment (Mini-mental state examination score \<26/30, CDR score \>0, memory complaints) (excluding AD, MCI groups). 20. Smoking. 21. Current or life-time drug or alcohol abuse 22. Untreated dyslipidemia, hypertension, or thyroid disease. 23. Antidepressant medications with anticholinergic properties. 24. Regular use of narcotic agents more than two doses per week within 4 weeks of screening. 25. Antiparkinsonian medications used within 4 weeks of screening. 26. Enrollment in any investigational drug studies within 4 weeks of screening. 27. Immunomodulating or oncological treatment. 28. Cardiac implantable electronic devices (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. 29. Metallic intraocular foreign bodies: patients who have ever welded without eye protection or had facial injuries involving metal must have an orbit x-ray reviewed by a radiologist before MRI. 30. Implantable neurostimulation systems. 31. Cochlear implants/ear implants. 32. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps). 33. Catheters with metallic components (e.g., Swan-Ganz catheter). 34. Metallic fragments (e.g., bullets, shotgun pellets, shrapnel). 35. Cerebral artery aneurysm clips. 36. Magnetic dental implants. 37. Tissue expanders. 38. Artificial limbs. 39. Non-removable hearing aids. 40. Non-removable piercings. 41. Implantable cardiocerter defibrillators 42. Cardiac resynchronization therapy devices 43. Fever (temperature \> 37.5°C measured prior to MRI). 44. Volunteers taking amphetamines or sedatives

Locations (1)

Translational Imaging Center / Sitem

Bern, Switzerland