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Spectroscopic Magnetic Resonance Imaging of Glioma (MEGA-PRESS)

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ClinicalTrials.gov Identifier: NCT03677999
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Brain Tumor-Glioma 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.

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Study Type : Observational
Estimated Enrollment : 304 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spectroscopic Magnetic Resonance Imaging of Glioma
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 14, 2024
Estimated Study Completion Date : September 14, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. The number of brain cancer participants with IDH mutation status [ Time Frame: 30 minutes ]
    MEGA-PRESS MRI sequence will be utilized to determine IDH status



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:   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.
Criteria

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

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): NCT03677999


Contacts
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Contact: Nonye Harcourt, MPH 6126248117 harco002@umn.edu
Contact: Clark Chen, MD., PhD ccchen@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Clark Chen, MD, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03677999    
Other Study ID Numbers: NEUROSURG-2018-26848
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years
Access Criteria: The link to the data will be made available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue