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

Malignant Central Nervous System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565367
• Other study ID #: IRB-39845
• Secondary ID: NCI-2018-01122IR
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Malignant Central Nervous System Neoplasm
• Metastatic Malignant Neoplasm in the Central Nervous System
• Neoplasms
• Nervous System Neoplasms

Intervention

Other:
• Gadolinium
gadolinium enhanced MRI

Drug:
• Hyperpolarized Carbon C 13 Pyruvate
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Magnetic Resonance Spectroscopic Imaging
Undergo MRSI

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Daniel M. Spielman	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue	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.	Imaging timepoint (up to 15 minutes to obtain scan)
Primary	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