Phase 1
N=9
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Malignant Central Nervous System Neoplasm · Metastatic Malignant Neoplasm in the Central Nervous System
Bottom Line
View on ClinicalTrials.gov: NCT03565367 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With Grade 2 or Higher Toxicities — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gadolinium (Other); Hyperpolarized Carbon C 13 Pyruvate (Drug); Magnetic Resonance Imaging (Procedure); Magnetic Resonance Spectroscopic Imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daniel M. Spielman
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 2 or Higher Toxicities |
0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03565367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.