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Metabolic Characterization of Space Occupying Lesions of the Brain (FASTMRSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233788
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment
Brain Tumor Glioma IDH Mutation Device: MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Metabolic Characterization of Space Occupying Lesions of the Brain Using in Vivo MR- (Spectroscopic) Imaging at 3 Tesla and 7 Tesla
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient Group 1 (15 Patients)
First two pulse sequence will be applied to this group at a 3T Prisma and a 7T Terra scanner. Best sequence propagates to Patient Group 2.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Patient Group 2 (15 Patients)
Two pulse sequence (one will be the best performing pulse sequence of Patient Group 1) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Best sequence propagates to Patient Group 3.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Patient Group 3 (15 Patients)
Two pulse sequence (one will be the best performing pulse sequence of Patient Group 2) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Best sequence propagates to Patient Group 4.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Patient Group 4 (15 Patients)
Two pulse sequence (one will be the best performing pulse sequence of Patient Group 3) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Best sequence propagates to Patient Group 5.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Patient Group 5 (15 Patients)
Two pulse sequence (one will be the best performing pulse sequence of Patient Group 4) will be applied to this group using a 3T Prisma and a 7T Terra scanner. At the end the best performing sequence will result.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 1 (10 Persons)
First two pulse sequences will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used as normative data.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 2 (10 Persons)
First two pulse sequences (one will be the best performing pulse sequence of Healthy Control Group 1) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used normative data.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 3 (10 Persons)
First two pulse sequences (one will be the best performing pulse sequence of Healthy Control Group 2) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used as normative data.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 4 (10 Persons)
First two pulse sequences (one will be the best performing pulse sequence of Healthy Control Group 3) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used normative data.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.

Healthy Control Group 5 (10 Persons)
First two pulse sequences (one will be the best performing pulse sequence of Healthy Control Group 4) will be applied to this group using a 3T Prisma and a 7T Terra scanner. Data will be used normative data.
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.
Other Name: Examined are fast MRSI sequences and CEST sequences.




Primary Outcome Measures :
  1. Optimal MR-sequence for IDH-typing [ Time Frame: 48 months ]
    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.


Secondary Outcome Measures :
  1. Spectral/CEST pattern [ Time Frame: 48 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233788


Contacts
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Contact: Johannes Slotboom, PhD +41316327469 johannes.slotboom@gmail.com
Contact: Marwan El-Koussy, MD +41316320008 marwan.el-koussy@insel.ch

Locations
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Switzerland
Institute for Diagnostic and Interventional Neuroradiology, University Hospital Bern
Bern, Switzerland, 3010
Contact: Johannes Slotboom, PhD    +41316327469    johannes.slotboom@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
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Study Chair: Johannes Slotboom, PhD University of Bern

Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04233788    
Other Study ID Numbers: 2019-00503
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital Inselspital, Berne:
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
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases