Clinical trial · Observational
Clinical Development of MR Spectroscopy and Imaging in Brain Cancers
NCT02731521CI-TRIAL-00056303completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytomas | Astrocytic Tumor | ALIAS | 0.90 |
| Malignant Gliomas | — | UNRESOLVED | — |
| Oligodendrogliomas | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla Scanning | Device | — | UNRESOLVED |
| 7 Tesla Scanning | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 3 Tesla Scanning and 7 Tesla Scanning
- description
- Scanning at 3 Tesla and 7 Tesla: Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS) of glioma and non-glioma patients.
- interventionNames
- Device: 3 Tesla Scanning
- Device: 7 Tesla Scanning
Primary outcomes (1)
- measure
- 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).
- timeFrame
- 1-4 scans, average over 36 months
- description
- Measuring amount of 2-hydroxygluterate (2HG) biomarker with MRS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.