At a glance
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A Phase 1 Ascending-dose Study to Assess the Safety and Tolerability and Imaging Potential of Hyperpolarized Pyruvate (13C) Injection in Subjects With Prostate Cancer
In Brief
A Phase 1 clinical trial evaluating Hyperpolarized Pyruvate (13C) injection for Prostate Cancer. Completed, enrolled 31 participants across 1 site.
Detailed Summary
Current imaging options do not assess prostate cancer well. This study will combine two magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to physicians and patients with prostate cancer in making treatment decisions and seeing how well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate will be injected into the body to determine how it is metabolized and how it's metabolism can be assessed using MR imaging. The purpose of this study is to determine the safety and metabolism of hyperpolarized pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging with regards to patient care.
Study Details
Timeline
Interventions
single hyperpolarized pyruvate IV (intravenous) injection followed by MR imaging scans (MRI and MRSI)