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Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors

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ClinicalTrials.gov Identifier: NCT03565367
Recruitment Status : Suspended (Logistics)
First Posted : June 21, 2018
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Daniel M. Spielman, Stanford University

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date August 4, 2021
Actual Study Start Date  ICMJE November 6, 2018
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
Incidence of Grade 2 or Higher Toxicities [ Time Frame: Day 4 ]
The measurement of this drug will be Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue [ Time Frame: Day 4 ]
The outcome is defined as the frequency of hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Official Title  ICMJE A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
Brief 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.
Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Malignant Central Nervous System Neoplasm
  • Metastatic Malignant Neoplasm in the Central Nervous System
Intervention  ICMJE
  • Other: Gadolinium
    gadolinium enhanced MRI
    Other Name: Gd
  • Drug: Hyperpolarized Carbon C 13 Pyruvate
    Given IV
    Other Names:
    • Hyperpolarized 13C-Pyruvate
    • Hyperpolarized Pyruvate (13C)
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Spectroscopic Imaging
    Undergo MRSI
    Other Names:
    • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
    • 1H-nuclear magnetic resonance spectroscopic imaging
    • Magnetic Resonance Spectroscopy
    • MRS
    • MRS Imaging
    • MRSI
    • Proton Magnetic Resonance Spectroscopic Imaging
Study Arms  ICMJE Experimental: Diagnostic (MRI, hyperpolarized carbon C 13 pyruvate MRSI)
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).
Interventions:
  • Other: Gadolinium
  • Drug: Hyperpolarized Carbon C 13 Pyruvate
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Spectroscopic Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 14, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03565367
Other Study ID Numbers  ICMJE IRB-39845
NCI-2018-01122 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-39845 ( Other Identifier: Stanford IRB )
BRN0036 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel M. Spielman, Stanford University
Study Sponsor  ICMJE Daniel M. Spielman
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Lawrence Recht Stanford University
PRS Account Stanford University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP