RecruitingPhase 2NCT04698564

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

Sponsor

University of Maryland, Baltimore

Enrollment

20 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of MRI scan that uses a tagged carbon molecule (hyperpolarized 13C-pyruvate) to detect prostate cancer and assess how aggressive it might be. The goal is to see if this new imaging technique can improve the accuracy of prostate cancer diagnosis. **You may be eligible if...** - You are between 40 and 80 years old - You have a high PSA level (>4 ng/ml), an abnormal prostate exam, or a known prostate cancer diagnosis - You are planning to have an MRI-guided biopsy or prostate removal surgery **You may NOT be eligible if...** - You cannot have an MRI scan (e.g., metal implants, pacemaker) - You cannot receive IV contrast dye - You have a pacemaker or other implanted electronic device - You have severe kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 \[Koletzko et al., 1997\].