NCT03830151

Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.

Detailed description

PRIMARY OBJECTIVES: I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson. SECONDARY OBJECTIVES: I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor. II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging. IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings. V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid \[RNA\], and deoxyribonucleic acid \[DNA\]). OUTLINE: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan. After completion of study, patients are followed up for 1 day.

Conditions

• Primary Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Hyperpolarized Carbon C 13 Pyruvate	Given IV
PROCEDURE	Magnetic Resonance Spectroscopic Imaging	Undergo MRSI

Timeline

• Start date: 2019-05-16
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2019-02-05
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study