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CompletedNCT02731521Updated Feb 3, 2022

Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

An observational study in Malignant Gliomas, Astrocytomas and Oligodendrogliomas, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
112
Ages
18 Years and older
Sex
All
01

Study summary

The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.

Read the detailed description

2-hydroxyglutarate (2HG) imaging will identify glioma, tumor progression and response to therapy noninvasively at an earlier time point than currently detectable with standard MR imaging. This utility of 2HG can be used for improving the patient care in a more effective manner when the 2HG imaging is incorporated in regular clinical MR scans in brain tumor patients. We aim to translate the 2HG MRS protocol into two clinical MR centers at UTSouthwestern Medical Center: The Mary Nell and Ralph B. Rogers Magnetic Resonance Center with Philips 1.5Tesla and 3Tesla scanners and The Algur H. Meadows Diagnostic Imaging Center with a GE 3Tesla scanner. In addition, we will perform Magnetic Resonance (MR) scans in patients with neurological diseases that can mimic gliomas, including stroke, epilepsy, encephalitis, and brain metastases in order to establish the specificity of 2HG to malignant gliomas.

02

Conditions studied

  • Malignant Gliomas
  • Astrocytomas
  • Oligodendrogliomas

Keywords

  • MRS Biomarkers
03

In context

Astrocytoma

420 studies on the registry are indexed under Astrocytoma; 76 are open to participants now.

This study's enrollment of 112 is close to the median of 104 across 53 observational studies indexed under Astrocytoma.

Browse Astrocytoma studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Glioma patients recruited from UTSW neurosurgery and neuro-oncology clinics.

Inclusion criteria

(120 Brain Tumor Patients)

  • All races and ethnicities

  • Must meet at least one of the 3 following criteria regarding diagnosis:

    • Histological diagnosis of a brain tumor
    • Pre-operative MR imaging suggestive of a brain tumor
    • Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)
  • Pretreatment evaluations required for eligibility include a medical history, physical examination, and neurological exam within 30 days prior to study entry.
  • Patient must be able to provide study-specific consent prior to study entry and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
  • Karnofsky performance status >70%

  • Life expectancy greater than 3 months.

    (50 Non-Tumor Neurological Disorders)

  • All races and ethnicities

  • Patients with clinically-proven multiple sclerosis, temporal lobe epilepsy, stroke, or encephalitis.

    (5 Health Volunteers)

  • 18-40 years of age
  • All races and ethnicities
  • Excellent general health

Exclusion criteria

Exclusion Criteria:

  • Under age 18
  • Cardiac pacemaker
  • Intracranial clips, metal implants, or external clips within 50 cm from the head
  • Metal in eye
  • Pregnancy
  • Claustrophobia
  • Obesity or any other factors that provide difficulty with supine pose in the magnet
  • Patients who are unable to provide informed consent
  • Patients who are pregnant or nursing
  • Patients with severe kidney dysfunction or uncontrolled cardiac dysfunction
  • Patients who are claustrophobic or have other contraindication to MRI, such as implanted pacemaker device, vascular clips, surgical clips, prosthetic valves, pace¬makers, otologic implants
  • Patients with uncontrolled psychiatric manifestations of their brain tumor
  • Patients for 7 Tesla scans can have no metal in the body
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • 3 Tesla Scanning and 7 Tesla Scanning

    Scanning at 3 Tesla and 7 Tesla: Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS) of glioma and non-glioma patients.

    Device: 3 Tesla Scanning · Device: 7 Tesla Scanning

Interventions

  • Device3 Tesla Scanning

    Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.

    Also known as: 3T MRI/MRS

  • Device7 Tesla Scanning

    Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.

    Also known as: 7T MRI/MRS

06

What researchers measure

Primary outcomes

  1. Amount of 2-hydroxyglutarate (2HG) bio-marker in 170 patients with clinically-proven brain metastasis, multiple sclerosis, epilepsy, stroke, or encephalitis using magnetic resonance spectroscopy (MRS).

    Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.

    Time frame: 1-4 scans, average over 36 months

07

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02731521
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
Cancer Prevention Research Institute of Texas
Responsible party
Sponsor
First posted
Apr 7, 2016
Start date
Jan 2014
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Feb 3, 2022

Study contacts

Changho Choi, PhD
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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