Recruiting
Phase 1

HP 13C-Pyruvate

Sponsor:

University of Maryland, Baltimore

Code:

NCT04772456

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Study Details

Brief 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

Glioma

Study ID

NCT04772456

Start date

Aug 11, 2020

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection.

  • Ages 18-80, including male and female
  • Suitable to undergo contrast-enhanced MRI
  • Negative serum pregnancy test

Exclusion Criteria:

  • Inability to undergo MRI scan
  • Inability to receive IV contrast secondary to severe reaction or renal insufficiency.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: metabolic MRI

Single-arm study in patients who have Glioma Perform metabolic magnetic resonance imaging on patient have a Glioma cancer to understand if metabolic MRI can be safely performed on this population

Interventions

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 \[Koletzko et al., 1997\].

Primary outcome measure

  • Accuracy of metabolic MRI to diagnose Glioma [ Time Frame: Within three years post treatment ]

Central Contacts and Locations

Central contacts

Rosy Njonkou Tchoquessi

4107066445rnjonkou@som.umaryland.edu

Locations

Rosy Njonkou Tchoquessi

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rosy Njonkou Tchoquessi

4107066445rnjonkou@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-09-22.