Metabolic Characterization of Space Occupying Lesions of the Brain

NCT04233788 | Recruiting DMC

• 1 other identifier: 2019-00503
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Brain Tumor; Glioma; IDH Mutation

Keywords

Magnetic Resonance Spectroscopic Imaging (MRSI); Chemical exchange saturation transfer imaging (CEST); Pulse sequence development; Preoperative prediction of IDH-status; Quantitative MR(S)I; Signal processing

Outcome Measures

Primary Outcomes (1)

• Optimal MR-sequence for IDH-typing

  Finding the most optimal (2HG-edited, radial kspace-sampled) EPSI MRSI/CEST technique for the initial diagnosis of gliomas with respect to IDH-typing. Pre-operative knowledge of the IDH-type is important information for further neurosurgical treatment.

  48 months

Secondary Outcomes (1)

• Spectral/CEST pattern

  48 months

Study Arms (4)

Sequence optimization (Healthy Control Group 1 (10 Persons))

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).

Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)

Healthy Control Group 2 (15 Persons)

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.

Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)

Patient Group 1: Comparison of 5 different spectral editing sequences (30 Patients)

Two editing pulse sequence types will be applied to this group at a 3T Prisma and a 7T Terra scanner. The sequences being compared are MEGA-semiLASER-SVS, MEGA-semiLASER based MRSI (on both 3T and 7T) and SLOW-EPSI (on 7T only).

Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)

Patient Group 1: Comparison of 4 different CEST sequences (30 Patients)

Two different CEST sequence types will be applied to this group at a 3T Prisma and a 7T Terra scanner. The CEST performance will be compared between 3T and 7T, as well which of the two types in the best on each scanner. Aim: which of the four sequence predicts the IDH-mutation status best.

Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)

Interventions

MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany) DEVICE

The MR-scans performed at 3T and 7T are performed to evaluate whether high field MR-examinations bring an advantage to the patient in determining the IDH-status of the glioma. Two MRSI/CEST sequences will be tested against each other.

Also known as: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 2 (15 Persons); Patient Group 1: Comparison of 4 different CEST sequences (30 Patients); Patient Group 1: Comparison of 5 different spectral editing sequences (30 Patients); Sequence optimization (Healthy Control Group 1 (10 Persons))

Eligibility Criteria

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

Study Population

Healthy controls: Each of the participating healthy adult persons in the study will receive 2 out of 5 different pulse sequences which will be tested against each other (5 groups with 10 healthy controls). In each group two pulse sequences will be tested against each other at 3T and 7T. The data of the healthy controls will be used an normal values to compare patient data against. Patients: 75 patients will be also be split in 5 groups groups of 15 patients. Each patient will receive 2 out of 5 MRSI and/or CEST pulse sequences which will be tested against each other in that group. The best pulse sequence is propagated to the next group. The pulse sequences will be applied at 3T and at 7T (when available). With this approach the researchers hope to find out the most accurate sequence that predicts the IDH-status pre-operatively.

You may qualify if:

• Healthy people who are able to lie in the MR scanner for one hour;
• Patients with suspected mass in the brain
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Institute for Diagnostic and Interventional Neuroradiology, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (5)

• Paech 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 BACKGROUND

• Choi 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 BACKGROUND

• Marjanska 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 BACKGROUND

• Sabati 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 BACKGROUND

• Slotboom 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 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Johannes Slotboom, PhD

  University of Bern

  STUDY CHAIR

Central Study Contacts

Johannes Slotboom, PhD

CONTACT

+41316327469; johannes.slotboom@gmail.com

Marwan El-Koussy, MD

CONTACT

+41316320008; marwan.el-koussy@insel.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)