Clinical trial · Observational
Clinical Development of Cancer-Specific MRS Biomarkers in Malignant Gliomas
NCT02388659CI-TRIAL-00063540completedClinicalTrials.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 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla scanning | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brain MRI/MRS Patients
- description
- 3 Tesla Scanning: MRI/MRS of glioma and non-glioma patients.
- interventionNames
- Device: 3 Tesla scanning
Primary outcomes (1)
- measure
- Identification of 2-hydroxygluterate (2HG) biomarker in 30 patients with clinically-proven brain metastasis, multiple sclerosis, epilepsy, stroke, or encephalitis using magnetic resonance spectroscopy (MRS).
- timeFrame
- 8 scans, average 36 months
- description
- The investigators anticipate the study will provide significant value in many aspects of management of gliomas. 3D evaluation of the cancer biomarkers using MRSI will provide biological insights for making the diagnosis of gliomas, tracking of infiltrative cells during follow up, and determining response to treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with brain tumors (55 subjects): * Age \> 18 years * Males and females * All races and ethnicity * Patients must meet at least one of the 3 following criteria regarding brain tumor diagnosis: * Histological diagnosis of a brain tumor * Pre-operative brain MR imaging suggestive of a brain tumor * Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem) * Pretreatment evaluation 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% Patients with non-tumor neurological disorders (50 subjects): * Males and females * All races and ethnicities * Patients with clinically-proven encephalitis (infections, autoimmune and paraneoplastic), demyelinating lesions, vascular lesions (subacute arterial infarct, venous infarct, and vasculitis), hamartomatous lesions, and malformations of cortical development. Exclusion Criteria: * Age under 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 cips, surgical slips, prosthetic valves, pacemakers, otologic implants. * Patients with uncontrolled psychiatric manifestations of their brain tumor. * Children (age \< 18) are excluded from the study plan because the incidence of astrocytomas and glioblastoma in children is far less than in adults. Although children frequently develop brain tumors, the glial tumors are most often pilocytic astrocytomas. In addition, enrollment of adults will be beneficial for the MRS sequence validation tests in healthy subjects since adults can remain motionless during the MR scans compared to children, giving minimal motion artifacts om the MR data.
References
Publications (0)
Data not yet available
No reference posted for this study.