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NCT04233788Recruiting

Metabolic Characterization of Space Occupying Lesions of the Brain

Official recordSimplified version

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland
Sponsor
Insel Gruppe AG, University Hospital Bern(Other)
Protocol no.
2019-00503
Conditions
Brain Tumor, Glioma, IDH Mutation
Interventions
Device

Treatments studied

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

Collaborators

Swiss National Science Foundation

Locations · 1

  • Bern, SwitzerlandInstitute for Diagnostic and Interventional Neuroradiology, University Hospital BernRecruiting at this site

In total, worldwide, the only site listed in the registry is recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: November 25, 2024).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2019 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.