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

Daniel M. Spielman

Status and phase: Completed; Phase 1

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03565367

NCI-2018-01122 (Registry Identifier)

R01CA245097-01A1 (U.S. NIH Grant/Contract)

IRB-39845 (Other Identifier)

BRN0036 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Carbon C 13 Pyruvate

Procedure: Magnetic Resonance Imaging

Procedure: Magnetic Resonance Spectroscopic Imaging

Known CNS Malignancy

Experimental group

Description:

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).

Treatment:

Drug: Hyperpolarized Carbon C 13 Pyruvate

Other: Gadolinium

Procedure: Magnetic Resonance Imaging

Procedure: Magnetic Resonance Spectroscopic Imaging