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

• Sponsor: Daniel M. Spielman (Other)
• Overall Status: Suspended
• CT.gov ID: NCT03565367
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 50.3
• Patients Per Site Per Month: 0.2

Study Details

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.

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:

1. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI).

2. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• 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: Nov 6, 2018
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 14, 2023

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Incidence of Grade 2 or Higher Toxicities [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Daniel M. Spielman
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Lawrence Recht, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel M. Spielman, Professor of Radiology, Stanford University
• ClinicalTrials.gov Identifier: NCT03565367
• Other Study ID Numbers: IRB-39845; NCI-2018-01122; IRB-39845; BRN0036
• First Posted: Jun 21, 2018
• Last Update Posted: Aug 4, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms

Study Results

No Results Posted as of Aug 4, 2021