NCT04233788 Metabolic Characterization of Space Occupying Lesions of the Brain
| NCT ID | NCT04233788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Brain Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2021-09-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Johannes Slotboom, PhD
STUDY CHAIR
University of Bern
Frequently Asked Questions
Who can join the NCT04233788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04233788 currently recruiting?
Yes, NCT04233788 is actively recruiting participants. Contact the research team at johannes.slotboom@gmail.com for enrollment information.
Where is the NCT04233788 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04233788 clinical trial?
NCT04233788 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Johannes Slotboom, PhD at University of Bern. The trial plans to enroll 55 participants.