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Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques

NCT06705010 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Johannes Slotboom, PhD · University Hospital / Inselspital /University Bern / 3010 Bern / Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-11-01
Completion
2028-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705010 on ClinicalTrials.gov