Spectroscopic Magnetic Resonance Imaging of Glioma

Brain Tumor-Glioma Clinical Trial

— MEGA-PRESS  

Official title:

Spectroscopic Magnetic Resonance Imaging of Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03677999
• Other study ID #: NEUROSURG-2018-26848
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: September 14, 2025

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: Nonye Harcourt, MPH
• Phone: 6126248117
• Email: harco002[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is designed to develop and test new Magnetic Resonance Imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants.

Description:

The primary objective of this study is to develop and test new Magnetic Resonance Imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants. More specifically, investigators are interested in applying novel spectroscopic and quantitative MR methods that give information beyond what is produced by a clinical brain MRI study and to understand the clinical correlates of the imaging findings. Investigators have tested these sequences in healthy volunteers. The investigators now wish to test these sequences in brain cancer participants in order to understand how these sequences can best be applied in a clinical setting.

To acquire these data, investigators intend to perform additional MRI acquisitions on participants who are scheduled to receive a clinical MRI at the UMN Center for Clinical Imaging Research (CCIR), a facility located at the Center for Magnetic Resonance Research (CMRR). Since these MRIs are required for the participants' clinical care, the participant will not be making additional visits to the CCIR. Based on published data and pilot experiences reported from other institutions, the sequences are well-tolerated. The only imposition for the participant is that the participant will spend additional time in the scanner after completion of the imaging required for clinical care. An informed consent form describing the additional MR sequences performed will be presented to the participant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: September 14, 2025
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women scheduled who are diagnosed with glioma who is seeking clinical care for their conditions at the UMN Masonic cancer center.

2. Passed the safety screen for MRI

3. Age 18 or older

4. Ability to read and understand English

5. Ability to provide informed consent

Exclusion Criteria:

1. Participants who are excluded from the base MRI scan, as determined by the CMRR/CCIR clinical policies are necessarily excluded from this study, as the MRI scan will not be performed.

2. Pregnant women

Related Conditions & MeSH terms

• Brain Tumor-Glioma
• Glioma

Intervention

Diagnostic Test:
• MEGA-PRESS sequence Magnetic Resonance Spectroscopy
MRS protocols and novel MRI methods that allow detection and quantification of 2 hydroxyglutarates (2HG) as well as the physiologic consequences of 2HG accumulation.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of brain cancer participants with IDH mutation status	MEGA-PRESS MRI sequence will be utilized to determine IDH status	30 minutes