Spectroscopic Magnetic Resonance Imaging of Glioma (MEGA-PRESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor-Glioma
• Intervention / Treatment: Diagnostic test: MEGA-PRESS sequence Magnetic Resonance Spectroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 304

Contacts and Locations

• Study Contact: Name: Nonye Harcourt, MPH; Phone Number: 6126248117; Email: harco002@umn.edu
• Study Contact Backup: Name: Clark Chen, MD., PhD; Email: ccchen@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Glioma who is seeking clinical care for their conditions at the UMN Masonic cancer center Aand scheduled to have standard of care MRI.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain tumor patients with Glioma; Men and women scheduled who are diagnosed with glioma who is seeking clinical care for their conditions at the UMN Masonic cancer center.; Passed the safety screen for MRI; Age 18 or older Participants will receive MEGA-PRESS sequence Magnetic Resonance Spectroscopy during their routined schedule standard of care MRI.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of brain cancer participants with IDH mutation status	MEGA-PRESS MRI sequence will be utilized to determine IDH status	30 minutes

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Clark Chen, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): September 14, 2024
• Study Completion (Estimated): September 14, 2025

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: NEUROSURG-2018-26848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data may be shared with other investigators via a web-based University of Minnesota Box secured storage. Box Secure Storage is a secure environment delivered by the Center of Excellence for HIPAA Data intended for storing, sharing and accessing sensitive and private-highly restricted files.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: The link to the data will be made available upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No