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Completed

NCT Number: NCT03565367

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

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.

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Key information

Conditions

Malignant Central Nervous System Neoplasm Central Nervous System Neoplasms Metastatic Malignant Neoplasm in the Central Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadolinium

Other

gadolinium enhanced MRI

Other names: Gd

Hyperpolarized Carbon C 13 Pyruvate

Drug

Given IV

Other names: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Magnetic Resonance Imaging

Procedure

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

magnetic resonance spectroscopic imaging

Procedure

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 outcomes

  1. Number of Participants With Grade 2 or Higher Toxicities

    Time frame: 2 days (+/-2) after the scan

    The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)

Other outcomes

  1. Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue

    Time frame: Imaging timepoint (up to 15 minutes to obtain scan)

    The outcome is defined as the number of participants with hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened.

Sponsors and collaborators

Lead sponsor

Daniel M. Spielman

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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