NCT06705010Not yet recruiting
Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques
Non-Invasive Monitoring of Brain Metabolites Using Novel and Adapted Proton and Deuterium MR Techniques
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Alzheimer disease, Type 2 diabetes
- NCT number
- NCT06705010
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Apr 2025 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active implants (e.g., pacemakers, neuro-stimulators).
- Passive ferromagnetic implants.
- Passive non-ferromagnetic metallic implants \> 4 cm in a region covered by the active radio frequency (RF) coils.
- Current or life-time drug or alcohol abuse
- Antidepressant medications with anticholinergic properties.
- Antiparkinsonian medications used within 4 weeks of screening.
- Enrollment in any investigational drug studies within 4 weeks of screening.
- Cochlear implants/ear implants.
- Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps).
- Magnetic dental implants.
- Fever (temperature \> 37.5°C measured prior to MRI).
Other illness
- Evidence of overt heart or renal disease.
- Evidence of gastrointestinal tract disease.
- Cognitive impairment (Mini-mental state examination score \<26/30, CDR score \>0, memory complaints) (excluding AD, MCI groups).
- Untreated dyslipidemia, hypertension, or thyroid disease.
- Cardiac implantable electronic devices (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices.
- Cardiac resynchronization therapy devices
Lab values
- Diabetes or glucose intolerance according to WHO recommendations (excluded in the diabetes patient group).
Age
- Under 18 years of age.
Other
- Claustrophobia.
- Pregnancy or current state of lactation.
- Large tattoos inside a region covered by the active RF coils.
- Known or suspected non-compliance.
- Underweight \<30 kg body weight.
- Body mass index (BMI) \> 30.
- Overweight \>135 kg
- Persons with extreme big head circumference or extreme astigmatism, which cannot be corrected by MR-compatible eyeglasses.
- Persons not able to understand the informed consent form.
- Not agreeing with the institute's policy to inform the subject on incidental findings discovered during the examination.
- Visual and auditory acuity impairing neuropsychological testing (if relevant).
- Smoking.
- Regular use of narcotic agents more than two doses per week within 4 weeks of screening.
- Immunomodulating or oncological treatment.
- 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.
- Implantable neurostimulation systems.
- Catheters with metallic components (e.g., Swan-Ganz catheter).
- Metallic fragments (e.g., bullets, shotgun pellets, shrapnel).
- Cerebral artery aneurysm clips.
- Tissue expanders.
- Artificial limbs.
- Non-removable hearing aids.
- Non-removable piercings.
- Implantable cardiocerter defibrillators
- Volunteers taking amphetamines or sedatives
Criteria the registry did not label
- General Inclusion Criteria (applicable to all groups):
- 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.
- Normal or corrected-to-normal vision.
- Disease-Specific Inclusion Criteria:
- 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.
- High-Grade Carotid Stenosis Patient Group (PG-IV-1H-HGCS):
- ≥50% stenosis of the carotid artery.
- 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.
Age in the registry: 18 years to 130 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Translational Imaging Center / Sitem Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.