Clinical trial · Observational
Metabolic Characterization of Space Occupying Lesions of the Brain
Metabolic Characterization of Space Occupying Lesions of the Brain Using in Vivo MR- (Spectroscopic) Imaging at 3 Tesla and 7 Tesla
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High field MR-technologies are expected to boost metabolic spectroscopic imaging (MRSI), but also CEST-MRI. This is due to the fact that increased SNR is available which can be used to increase the spatial resolution of all sequences, or reduction of measurement times. Recent findings has shown that MRSI can be used to evaluate the isocitrate dehydrogenase (IDH) status of gliomas, a brain tumor type which is most often diagnosed in humans. Patients with IDH-mutated gliomas have a much longer survival time that IDH-wildtype. In IDH-mutated gliomas the substance 2-hydroxy-glutarate (2HG) is found, whereas in IDH-wildtype gliomas it is not. The underlying trial aims to measure 2HG directly with different MRSI sequences at 3 Tesla (3T) and 7 Tesla (7T) magnetic field strength. Apart from MRSI-techniques for IDH-typing it has been shown that CEST-imaging can also be performed to determine the IDH-status of gliomas. A total of 75 patients and 50 healthy controls will be examined in this study to evaluate the most accurate method for pre-operative IDH-status determination.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| IDH Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Sequence optimization (Healthy Control Group 1 (10 Persons))
- description
- The MEGA-based editing sequences as well as the SLOW-EPSI sequence will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used for optimization of the pulse sequences. Aim: find those sequence parameters to obtain best spectral quality data (SNR, spatial resolution versus measurement time).
- interventionNames
- Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)
- label
- Healthy Control Group 2 (15 Persons)
- description
- The best performing sequence which will be applied to this group using a 7T Terra scanner. Data will be used normative data for glutamate/glutamine and GABA levels in healthy controls. Aim: normal reference data for future studies.
- interventionNames
- Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)
- label
- Patient Group 1: Comparison of 5 different spectral editing sequences (30 Patients)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy people who are able to lie in the MR scanner for one hour; * Patients with suspected mass in the brain * Written informed consent Exclusion Criteria: * Persons under the age of 18 * Persons who are mentally unable to choose to participate * Pregnant women * Patients with oncological findings or neurodegenerative findings in the past * Wearing active implants (e.g. pacemakers and neurostimulators) * Emergency patients * Persons with tattoos on the head or neck area
References
Publications (5)
- BACKGROUNDPaech D, Windschuh J, Oberhollenzer J, Dreher C, Sahm F, Meissner JE, Goerke S, Schuenke P, Zaiss M, Regnery S, Bickelhaupt S, Baumer P, Bendszus M, Wick W, Unterberg A, Bachert P, Ladd ME, Schlemmer HP, Radbruch A. Assessing the predictability of IDH mutation and MGMT methylation status in glioma patients using relaxation-compensated multipool CEST MRI at 7.0 T. Neuro Oncol. 2018 Nov 12;20(12):1661-1671. doi: 10.1093/neuonc/noy073. PMID 29733378
- BACKGROUNDChoi C, Ganji SK, DeBerardinis RJ, Hatanpaa KJ, Rakheja D, Kovacs Z, Yang XL, Mashimo T, Raisanen JM, Marin-Valencia I, Pascual JM, Madden CJ, Mickey BE, Malloy CR, Bachoo RM, Maher EA. 2-hydroxyglutarate detection by magnetic resonance spectroscopy in IDH-mutated patients with gliomas. Nat Med. 2012 Jan 26;18(4):624-9. doi: 10.1038/nm.2682. PMID 22281806
- BACKGROUNDMarjanska M, Auerbach EJ, Valabregue R, Van de Moortele PF, Adriany G, Garwood M. Localized 1H NMR spectroscopy in different regions of human brain in vivo at 7 T: T2 relaxation times and concentrations of cerebral metabolites. NMR Biomed. 2012 Feb;25(2):332-9. doi: 10.1002/nbm.1754. Epub 2011 Jul 27. PMID 21796710
- BACKGROUNDSabati M, Sheriff S, Gu M, Wei J, Zhu H, Barker PB, Spielman DM, Alger JR, Maudsley AA. Multivendor implementation and comparison of volumetric whole-brain echo-planar MR spectroscopic imaging. Magn Reson Med. 2015 Nov;74(5):1209-20. doi: 10.1002/mrm.25510. Epub 2014 Oct 29. PMID 25354190
- BACKGROUNDSlotboom J, Boesch C, Kreis R. Versatile frequency domain fitting using time domain models and prior knowledge. Magn Reson Med. 1998 Jun;39(6):899-911. doi: 10.1002/mrm.1910390607. PMID 9621913