Magnetic Resonance SpectroscopyNIMM_MRSNCT05165537
Non-Invasive Monitoring Of Metabolite Levels Using Novel And Adapted MR Spectroscopy Techniques
A study testing NIMM_MRS in people with Magnetic Resonance Spectroscopy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Spectroscopy
- What is being tested?
- NIMM_MRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Translational Imaging Center
Bern, PhD, 3010
Roland Kreis, PhD, 0316328174, roland.kreis@insel.ch
roland.kreis@insel.ch
About this study
Official title: Evaluation of Novel and Adapted MR Spectroscopy and Metabolic Imaging Techniques for Non-invasive Monitoring of Metabolite Levels in Humans in Physiologic States of Everyday Life
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).
Read more
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).
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.
Read the detailed description
Magnetic resonance imaging (MRI) and spectroscopy (MRS) provide non-invasive modalities to explore human morphology, function and metabolism. MRS methods are in widespread use in clinical research and to some degree in clinical applications. MRS methodology has been continuously extended for the last 30 years. All extensions employing novel MR pulse sequences (acquisition software), acquisition hardware capabilities of MRI scanners or post-processing methods have to be validated in theory, and in practice, where they are first tested in vitro and then in healthy subjects. The proposed project is based on a SNF project and a Horizon 2020 project of the sponsor-investigator, where multiple methodological extensions of MRS sequences are implemented for improved measurements of metabolite levels, characteristics and maps.
The intended study uses MRI-scanners which have a Conformité Européenne (CE) label for diagnostic use. The manufacturer of the MR scanner provides a "research-license mode" with the very same hardware; however, since the flexibility of this mode of operation makes a CE process prohibitively long and complex, no CE label was aimed at for the research-license mode.
The methodological developments within the proposed study aim at novel or improved sequences, which have the potential to observe previously undetectable metabolites and to evaluate metabolite changes as function of time-of-day or previous exercise. The sequences are applied in investigations of healthy adult subjects in everyday physiological situations to document the potential of the novel methods in terms of accuracy, precision, robustness. Without such investigations on healthy subjects the methodological advances cannot be verified in a valid situation and thus not ported to more specific research trials or clinical applications.
- Conditions
- Magnetic Resonance Spectroscopy
- Being tested
- NIMM_MRS
- Keywords
- brain, muscle, healthy subjects, precision, repeatability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIMM_MRSDevice
evaluation of new MRS methods
| Study group | Role | What they receive |
|---|---|---|
| NIMM_MRS | Experimental | testing of new MRS methods Receives: Device: NIMM_MRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Mar 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance SpectroscopyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Kreis, PhD, Principal investigator, Inselspital Bern & University Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165537
- Sponsor's protocol ID
- NIMM_MRS
- Acronym
- NIMM_MRS
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel and Adapted MR Spectroscopy and Metabolic Imaging Techniques for Non-invasive Monitoring of Metabolite Levels in Humans in Physiologic States of Everyday Life
- ClinicalTrials.gov ID
- NCT05165537
- Acronym / sponsor ID
- NIMM_MRS / NIMM_MRS
- Conditions
- Magnetic Resonance Spectroscopy
- Keywords
- brain, muscle, healthy subjects, precision, repeatability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Detailed description
Magnetic resonance imaging (MRI) and spectroscopy (MRS) provide non-invasive modalities to explore human morphology, function and metabolism. MRS methods are in widespread use in clinical research and to some degree in clinical applications. MRS methodology has been continuously extended for the last 30 years. All extensions employing novel MR pulse sequences (acquisition software), acquisition hardware capabilities of MRI scanners or post-processing methods have to be validated in theory, and in practice, where they are first tested in vitro and then in healthy subjects. The proposed project is based on a SNF project and a Horizon 2020 project of the sponsor-investigator, where multiple methodological extensions of MRS sequences are implemented for improved measurements of metabolite levels, characteristics and maps.
The intended study uses MRI-scanners which have a Conformité Européenne (CE) label for diagnostic use. The manufacturer of the MR scanner provides a "research-license mode" with the very same hardware; however, since the flexibility of this mode of operation makes a CE process prohibitively long and complex, no CE label was aimed at for the research-license mode.
The methodological developments within the proposed study aim at novel or improved sequences, which have the potential to observe previously undetectable metabolites and to evaluate metabolite changes as function of time-of-day or previous exercise. The sequences are applied in investigations of healthy adult subjects in everyday physiological situations to document the potential of the novel methods in terms of accuracy, precision, robustness. Without such investigations on healthy subjects the methodological advances cannot be verified in a valid situation and thus not ported to more specific research trials or clinical applications.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIMM_MRS | Experimental | Device: NIMM_MRStesting of new MRS methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIMM_MRSevaluation of new MRS methods | Device | NIMM_MRS |
Primary outcome
healthy-cohort signal intensity characteristics for metabolites of interest (MOI)
Time frame: 2 months
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
1 secondary outcome
healthy-cohort signal resolution and uncertainty characteristics for metabolites of interest (MOI)
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland Kreis, PhD principal investigator
Inselspital Bern & University Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIMM_MRS in people with Magnetic Resonance Spectroscopy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Kreis, PhD (+41316328174, roland.kreis@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healthy-cohort signal intensity characteristics for metabolites of interest (MOI) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.