Study Stopped
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Spectroscopic Magnetic Resonance Imaging of Glioma
MEGA-PRESS
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2025
CompletedFebruary 17, 2025
February 1, 2025
5.3 years
September 13, 2018
February 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The number of brain cancer participants with IDH mutation status
MEGA-PRESS MRI sequence will be utilized to determine IDH status
30 minutes
Study Arms (1)
Brain tumor patients with Glioma
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.
Interventions
MRS protocols and novel MRI methods that allow detection and quantification of 2 hydroxyglutarates (2HG) as well as the physiologic consequences of 2HG accumulation.
Eligibility Criteria
Glioma who is seeking clinical care for their conditions at the UMN Masonic cancer center Aand scheduled to have standard of care MRI.
You may qualify if:
- 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
- Ability to read and understand English
- Ability to provide informed consent
You may not qualify if:
- 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.
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Clark Chen, MD, PhD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 19, 2018
Study Start
June 1, 2019
Primary Completion
September 14, 2024
Study Completion
September 14, 2025
Last Updated
February 17, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- 2 years
- Access Criteria
- The link to the data will be made available upon request
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.