Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
NCT ID: NCT03565367
Last Updated: 2023-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2018-11-06
2019-06-20
Brief Summary
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Detailed Description
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I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized \[1-13C\] pyruvate) for magnetic resonance imaging (MRI).
II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized \[1-13C\] pyruvate.
OUTLINE:
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 magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
After completion of study, participants are followed up periodically.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Volunteers
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.
Hyperpolarized Carbon C 13 Pyruvate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Known CNS Malignancy
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).
Gadolinium
gadolinium enhanced MRI
Hyperpolarized Carbon C 13 Pyruvate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Interventions
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Gadolinium
gadolinium enhanced MRI
Hyperpolarized Carbon C 13 Pyruvate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Daniel M. Spielman
OTHER
Responsible Party
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Daniel M. Spielman
Professor of Radiology
Principal Investigators
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Lawrence Recht
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-01122
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-39845
Identifier Type: OTHER
Identifier Source: secondary_id
BRN0036
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-39845
Identifier Type: -
Identifier Source: org_study_id