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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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:

1. A new method is developed and optimized theoretically and in sample preparations (solutions of chemicals). 2. The new methodology is evaluated in single healthy volunteers and optimized step by step for the conditions of use in the human body. 3. The methodology in evaluated in small groups of healthy volunteers (measurement accuracy and range of variation in healthy volunteers). 4. Feasibility is studied in different situations with possibly different metabolic situations (e.g. awake versus asleep or before and after muscular exertion).

For this purpose, about 100 subjects will be measured for different subprojects. Thus, among other things, one determines the measurement accuracy and also normal values in healthy subjects for the assessment of diseases in future studies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

<18 yrs of age

pregnancy or current state of lactation

active implants

passive ferromagnetic implants

Trial design

Design model

Single group

Treatments tested in this trial

  • NIMM_MRS

    Device

    evaluation of new MRS methods

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: NIMM_MRSExperimental treatment 1 intervention

Trial outcomes

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

Time frame
2 months

Secondary outcomes

1

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

cohort characteristics of the resolution parameters (full width at half maximum intensity) and (where a fitting model is available) the uncertainties of the model fit from single subjects

Time frame
2 months

Other outcomes

Sponsors and contacts

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