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

NCT03565367 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB-39845NCI-2018-01122BRN0036R01CA245097-01A1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 2 or Higher Toxicities

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

  2 days (+/-2) after the scan

Other Outcomes (1)

• Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue

  Imaging timepoint (up to 15 minutes to obtain scan)

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

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.

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Known CNS Malignancy

EXPERIMENTAL

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; Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Interventions

Gadolinium OTHER

gadolinium enhanced MRI

Also known as: Gd

Known CNS Malignancy

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Healthy Volunteers; Known CNS Malignancy

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Healthy Volunteers; Known CNS Malignancy

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MRSI

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging

Healthy Volunteers; Known CNS Malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel M. Spielman: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Gadolinium; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Lawrence Recht, MD
• Organization: Stanford University

lrecht@stanford.edu

(650) 725-8630

Study Officials

• Lawrence Recht

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: November 6, 2018
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: December 21, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)