Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
1 other identifier
observational
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 3, 2022
January 1, 2022
8 years
March 2, 2016
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
3 Tesla Scanning and 7 Tesla Scanning
Scanning at 3 Tesla and 7 Tesla: Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS) of glioma and non-glioma patients.
Interventions
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.
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.
Eligibility Criteria
Glioma patients recruited from UTSW neurosurgery and neuro-oncology clinics.
You may qualify if:
- (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)
- years of age
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changho Choi, PhD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2016
First Posted
April 7, 2016
Study Start
January 1, 2014
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
February 3, 2022
Record last verified: 2022-01