Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05165537 |
| Other study ID # |
NIMM_MRS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Insel Gruppe AG, University Hospital Bern |
| Contact |
Roland Kreis, PhD |
| Phone |
+41316328174 |
| Email |
roland.kreis[@]insel.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
