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Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

NCT04772456 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-22

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging

The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study.

Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).

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

Principal Investigators

  • Dirk Mayer, Dr. rer. nat · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2026-08-31
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 NCT04772456 on ClinicalTrials.gov