Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
University of Maryland, Baltimore
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
Eligibility
- Age range
- 40–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Age greater than 40 and less than 80 years 2. Clinical suspicion or history of prostate cancer reflected by one of the following: * PSA \> 4ng/ml * Abnormal DRE exam * Known tissue diagnosis of prostate cancer from prior workup 3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment Exclusion Criteria: 1. Inability to undergo MRI scan 2. Inability to receive IV contrast as per institutional protocol.
Interventions
- DrugHyperpolarized 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 \[Koletzko et al., 1997\].
Location
- University of Maryland Medical CenterBaltimore, Maryland