Spectroscopic Magnetic Resonance Imaging of Glioma

Recruiting

• Conditions: Brain Tumor-Glioma
• Interventions: Diagnostic Test: MEGA-PRESS sequence Magnetic Resonance Spectroscopy

• Registration Number: NCT03677999
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Study Start: 2019-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-09-14
• Study Completion: 2025-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain tumor patients with Glioma	MEGA-PRESS sequence Magnetic Resonance Spectroscopy	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 Participants will receive MEGA-PRESS sequence Magnetic Resonance Spectroscopy during their routined schedule standard of care MRI.

Primary Outcome Measures

Name	Time	Method
The number of brain cancer participants with IDH mutation status	30 minutes	MEGA-PRESS MRI sequence will be utilized to determine IDH status

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States