Clinical trial · Interventional
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
NCT03830151CI-TRIAL-00118238recruitingPhase 1ClinicalTrials.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)
This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Brain Neoplasm | Primary Brain Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | Drug | — | UNRESOLVED |
| Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (carbon C 13 pyruvate, MRSI)
- description
- Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
- interventionNames
- Drug: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Spectroscopic Imaging
Primary outcomes (1)
- measure
- Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
- timeFrame
- Up to 1 year
- description
- The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.
Secondary outcomes (6)
- measure
- Ki-67 quantitation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent will be obtained from each participants including healthy volunteers. * Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria. * All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial * Patient is \>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study. * Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor. * Patient is able to understand and give consent to participation in the study. * Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging. * Patient has a GFR \> 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary. * Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy. Exclusion Criteria: * Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria. * The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed. * Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication * Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (\> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating. * History of cardiac arrhythmia
References
Publications (0)
Data not yet available
No reference posted for this study.