NCT04698564

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Hyperpolarized 13C-Pyruvate	Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") \[ 13C\]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize \[13C\]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy. Hyperpolarized Pyruvate (13C) Injection and \[13C\]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as \[1- 13C\]pyruvate, \[2- 13C\]pyruvate and \[1,2- 13C\]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body \[Koletzko et al., 1997\].

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2021-01-07
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study