Non-Invasive Monitoring Of Metabolite Levels Using Novel And Adapted MR Spectroscopy Techniques

NCT05165537 | Recruiting

• 1 other identifier: NIMM_MRS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This Swiss National Science Foundation (SNF) funded project and the linked European project aim

• to improve magnetic resonance (MR) methods, specifically MR spectroscopy and metabolic imaging (making them more sensitive and accurate - also less dependent on motion),
• to extend them (making previously unobservable metabolites visible) and also
• to make them more stable (suitable for routine clinical use). Magnetic resonance spectroscopy (MRS) is closely related to the widely used magnetic resonance imaging (MRI). Both methods are based on the same physical effect and are performed on the same equipment. However, while MRI mainly images the anatomy inside the body, MRS gives us information about the metabolism of the tissue. The main goal of this study is to develop and improve methods of MRS to better measure the concentrations of endogenous substances without actual intervention. MRS methodology development is performed in 4 steps:
• A new method is developed and optimized theoretically and in sample preparations (solutions of chemicals).
• The new methodology is evaluated in single healthy volunteers and optimized step by step for the conditions of use in the human body.
• The methodology in evaluated in small groups of healthy volunteers (measurement accuracy and range of variation in healthy volunteers).
• Feasibility is studied in different situations with possibly different metabolic situations (e.g. awake versus asleep or before and after muscular exertion).

Conditions

Magnetic Resonance Spectroscopy

Keywords

brain; muscle; healthy subjects; precision; repeatability

Outcome Measures

Primary Outcomes (1)

• healthy-cohort signal intensity characteristics for metabolites of interest (MOI)

  healthy-cohort signal intensity characteristics for MOI as targeted by newly developed/optimized MRS sequences. Novel MRS sequences will be administered in a small cohort of healthy subjects and each sequence will provide detection/quantification of one or multiple specific metabolites (or metabolite characteristics (e.g. diffusivity)). Respective cohort averages and standard deviations of those signal intensities relative to the averaged signal noise per subject are the prime outcomes

  2 months

Secondary Outcomes (1)

• healthy-cohort signal resolution and uncertainty characteristics for metabolites of interest (MOI)

  2 months

Study Arms (1)

NIMM_MRS

EXPERIMENTAL

testing of new MRS methods

Device: NIMM_MRS

Interventions

NIMM_MRS DEVICE

evaluation of new MRS methods

NIMM_MRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• healthy (no neuronal or metabolic diseases as stated by the study participant)
• able to lie still in the MR scanner for at least one hour

You may not qualify if:

• \<18 yrs of age
• pregnancy or current state of lactation
• active implants
• passive ferromagnetic implants
• passive non-ferromagnetic metallic implants \> 4 cm inside a region covered by the active radio-frequency (RF) coils
• large tattoos inside a region covered by the active RF coils
• known or suspected non-compliance,
• under-weight (\<35 kg body weight)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Translational Imaging Center

Bern, PhD, 3010, Switzerland

RECRUITING

Related Links

• project description on funders portal

Study Officials

• Roland Kreis, PhD

  Inselspital Bern & University Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Kreis, PhD

CONTACT

+41316328174; roland.kreis@insel.ch

Karin Zwygart

CONTACT

+41316328174; karin.zwygart@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)