Multiple Sclerosis Clinical Trial

Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Estimated Enrollment:

112

Study ID:

NCT02731521

Recruitment Status:

Completed

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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UT Southwestern Medical Center
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

112

Study ID:

NCT02731521

Recruitment Status:

Completed

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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