Clinical Development of MR Spectroscopy and Imaging in Brain Cancers



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 2014
End Date:December 2020
Contact:Jeannie Baxter, RN
Email:jeannie.baxter@utsouthwestern.edu
Phone:214-645-2726

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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.

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.

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
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Changho Choi, PhD
Phone: 214-645-2726
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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