Clinical trial · Interventional
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
NCT03565367CI-TRIAL-00072472completedPhase 1Results postedClinicalTrials.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 early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Central Nervous System Neoplasm | Malignant Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Metastatic Malignant Neoplasm in the Central Nervous System | Central Nervous System Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadolinium | Other | — | UNRESOLVED |
| Hyperpolarized Carbon C 13 Pyruvate | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Healthy Volunteers
- description
- Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
- interventionNames
- Drug: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Imaging
- Procedure: Magnetic Resonance Spectroscopic Imaging
- type
- EXPERIMENTAL
- label
- Known CNS Malignancy
- description
- Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
- interventionNames
- Other: Gadolinium
- Drug: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI * Glomerular filtration rate (GFR) \> 30 ml/min * No allergy to gadolinium * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Refusal to have an IV placed for injection * Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement * Total bilirubin \> 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN * Gamma-glutamyltransferase (GGT) \> 2.5 x ULN * Pregnant or breast-feeding * Cardiovascular risk, including: * Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110 * Congestive heart failure * Myocardial infarction within the past year * QT prolongation, defined as pretreatment corrected QT interval (QTc) \> 440 msec in males or \> 460 msec in females
References
Publications (0)
Data not yet available
No reference posted for this study.