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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02731521
Other study ID # STU 122013-077
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

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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