Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

NCT04772456 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HP-00086612
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of metabolic MRI to diagnose Glioma

  To study the accuracy of hyperpolarized metabolic MRI to diagnose Glioma Cancer. We will compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score . Actual diagnosis of cancer will be based on tissue pathology.

  Within three years post treatment

Secondary Outcomes (1)

• Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer

  Within three years post treatment

Study Arms (1)

metabolic MRI

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Interventions

Hyperpolarized 13C-Pyruvate 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 \[Koletzko et al., 1997\].

metabolic MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Rosy Njonkou Tchoquessi

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Dirk Mayer, Dr. rer. nat

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosy Njonkou Tchoquessi

CONTACT

4107066445; rnjonkou@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: August 11, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)