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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

Primary Purpose

Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gadolinium
Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopic Imaging
Sponsored by
Daniel M. Spielman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Central Nervous System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (MRI, hyperpolarized carbon C 13 pyruvate MRSI)

Arm 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).

Outcomes

Primary Outcome Measures

Incidence of Grade 2 or Higher Toxicities
The measurement of this drug will be Grade 2 or higher related adverse events (except for asymptomatic lab increases)

Secondary Outcome Measures

Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue
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.

Full Information

First Posted
June 11, 2018
Last Updated
August 2, 2021
Sponsor
Daniel M. Spielman
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03565367
Brief Title
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Official Title
A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Suspended
Why Stopped
Logistics
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel M. Spielman
Collaborators
National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (MRI, hyperpolarized carbon C 13 pyruvate MRSI)
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Gd
Intervention Description
gadolinium enhanced MRI
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Carbon C 13 Pyruvate
Other Intervention Name(s)
Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopic Imaging
Other Intervention Name(s)
1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo MRSI
Primary Outcome Measure Information:
Title
Incidence of Grade 2 or Higher Toxicities
Description
The measurement of this drug will be Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue
Description
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.
Time Frame
Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Recht
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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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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