Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

NCT ID: NCT04772456

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hyperpolarized 13C-Pyruvate

Intervention Type DRUG

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 \[Koletzko et al., 1997\].

Interventions

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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 \[Koletzko et al., 1997\].

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Dirk Mayer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk Mayer, Dr. rer. nat

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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Rosy Njonkou Tchoquessi

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rosy Njonkou Tchoquessi

Role: CONTACT

4107066445

Facility Contacts

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Rosy Njonkou Tchoquessi

Role: primary

4107066445

Other Identifiers

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HP-00086612

Identifier Type: -

Identifier Source: org_study_id

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