Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

Correlation of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging and Tumor Histopathology in Patients With Infiltrating Gliomas

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).

Study Overview

• Status: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Drug: Hyperpolarized 13C-Pyruvate

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rosy Njonkou Tchoquessi; Phone Number: 4107066445; Email: rnjonkou@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Rosy Njonkou Tchoquessi
      • Contact: Rosy Njonkou Tchoquessi; Phone Number: 410-706-6445; Email: rnjonkou@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer	To examine the added utility of metabolic MRI over standard MRI imaging. 3. We will quantify the number of participants in which the MRI provided extra information that otherwise was not available during the course of the patient's workup.	Within three years post treatment

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Dirk Mayer, Dr. rer. nat, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: HP-00086612

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No