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Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

NCT04698564 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

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 \[Koletzko et al., 1997\].

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698564 on ClinicalTrials.gov