CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Hyperpolarized Pyruvate (13C) injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01229618
NCT01229618Phase 1Completed

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

University of California, San Francisco·interventional·Posted Oct 28, 2010·Updated Oct 5, 2015

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGE Healthcare

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago

Interventions

Hyperpolarized Pyruvate (13C) injectiondrug

single hyperpolarized pyruvate IV (intravenous) injection followed by MR imaging scans (MRI and MRSI)