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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04233788
Other study ID # 2019-00503
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2023

Study information

Verified date January 2023
Source University Hospital Inselspital, Berne
Contact Johannes Slotboom, PhD
Phone +41316327469
Email johannes.slotboom@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Institute for Diagnostic and Interventional Neuroradiology, University Hospital Bern Bern

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 Spectral/CEST pattern The retrospective analysis of tumor affected tissue volumes identified by 3D-MRSI/CEST image data with the factual resected volumes during 5-ALA guided complete tumor resection interventions enable to find the relationship between the spectral or CEST pattern and the location of the glioma. 48 months
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