Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

Completed

• Conditions: Astrocytomas; Malignant Gliomas; Oligodendrogliomas
• Interventions: Device: 3 Tesla Scanning; Device: 7 Tesla Scanning

• Registration Number: NCT02731521
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-07
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).	1-4 scans, average over 36 months	Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States