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

Phase 1

Completed

• Conditions: Metastatic Malignant Neoplasm in the Central Nervous System; Malignant Central Nervous System Neoplasm
• Interventions: Other: Gadolinium; Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

• Registration Number: NCT03565367
• Lead Sponsor: Daniel M. Spielman

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 Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Study Start: 2018-11-06
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2023-11
• Results First Submitted: 2023-11-27
• Results First Submitted QC: 2023-11-27
• Results First Posted: 2023-12-18
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Magnetic Resonance Imaging	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.
Healthy Volunteers	Magnetic Resonance Spectroscopic Imaging	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.
Known CNS Malignancy	Gadolinium	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).
Known CNS Malignancy	Magnetic Resonance Imaging	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).
Known CNS Malignancy	Magnetic Resonance Spectroscopic Imaging	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).
Healthy Volunteers	Hyperpolarized Carbon C 13 Pyruvate	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.
Known CNS Malignancy	Hyperpolarized Carbon C 13 Pyruvate	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Grade 2 or Higher Toxicities	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)

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States