Spectroscopic Magnetic Resonance Imaging of Glioma (MEGA-PRESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03677999|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment|
|Brain Tumor-Glioma||Diagnostic Test: MEGA-PRESS sequence Magnetic Resonance Spectroscopy|
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|
|Estimated Enrollment :||304 participants|
|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|
Brain tumor patients with Glioma
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.
- 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
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
|Contact: Nonye Harcourt, MPHemail@example.com|
|Contact: Clark Chen, MD., PhDfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Clark Chen, MD, PhD||University of Minnesota|