Malignant Gliomas Clinical Trial
Official title:
Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
Verified date | January 2022 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, paceĀ¬makers, otologic implants - Patients with uncontrolled psychiatric manifestations of their brain tumor - Patients for 7 Tesla scans can have no metal in the body |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Cancer Prevention Research Institute of Texas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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