Metabolic Characterization of Space Occupying Lesions of the Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial accepts healthy volunteersQualifiers
Healthy people who are able to lie in the MR scanner for one hour;
Patients with suspected mass in the brain
Written informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)
DeviceThe 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.
Treatment groups
55 Participants
are divided into 4 treatment groupsGroup A: Sequence optimization (Healthy Control Group 1 (10 Persons))1 intervention
Group B: Healthy Control Group 2 (15 Persons)1 intervention
Group C: Patient Group 1: Comparison of 5 different spectral editing sequences (30 Patients)1 intervention
Group D: Patient Group 1: Comparison of 4 different CEST sequences (30 Patients)1 intervention
Trial outcomes
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.
Time frame
48 monthsSecondary outcomes
1
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.
Time frame
48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov