Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

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.

Study Overview

• Status: Completed
• Conditions: Malignant Gliomas; Astrocytomas; Oligodendrogliomas
• Intervention / Treatment: Device: 3 Tesla Scanning; Device: 7 Tesla Scanning

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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: 3T MRI/MRS; Device: 7 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.; Other Names: 7T MRI/MRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-4 scans, average over 36 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Changho Choi, PhD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: MRS Biomarkers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioma; Brain Neoplasms; Astrocytoma; Oligodendroglioma
• Other Study ID Numbers: STU 122013-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED