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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 : Recruiting
First Posted : June 21, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel M. Spielman, Stanford University

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.

Condition or disease Intervention/treatment Phase
Malignant Central Nervous System Neoplasm Metastatic Malignant Neoplasm in the Central Nervous System Other: Gadolinium Drug: Hyperpolarized Carbon C 13 Pyruvate Procedure: Magnetic Resonance Imaging Procedure: Magnetic Resonance Spectroscopic Imaging Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565367


Contacts
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Contact: Stephanie Lewis 650-723-0381 lewisste@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Hari Priya Yerraballa    650-724-9363    yhpriya@stanford.edu   
Principal Investigator: Lawrence Recht         
Sponsors and Collaborators
Daniel M. Spielman
Investigators
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Principal Investigator: Lawrence Recht Stanford University

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Responsible Party: Daniel M. Spielman, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03565367     History of Changes
Other Study ID Numbers: IRB-39845
NCI-2018-01122 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-39845 ( Other Identifier: Stanford IRB )
BRN0036 ( Other Identifier: OnCore )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Neoplasms
Central Nervous System Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases