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Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

Primary Purpose

Glioma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 13C-Pyruvate
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rosy Njonkou TchoquessiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metabolic MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 23, 2021
Last Updated
October 5, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT04772456
Brief Title
Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas
Official Title
Correlation of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging and Tumor Histopathology in Patients With Infiltrating Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metabolic MRI
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 13C-Pyruvate
Intervention Description
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 Information:
Title
Accuracy of metabolic MRI to diagnose Glioma
Description
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.
Time Frame
Within three years post treatment
Secondary Outcome Measure Information:
Title
Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer
Description
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.
Time Frame
Within three years post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosy Njonkou Tchoquessi
Phone
4107066445
Email
rnjonkou@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Mayer, Dr. rer. nat
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rosy Njonkou Tchoquessi
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosy Njonkou Tchoquessi
Phone
410-706-6445
Email
rnjonkou@som.umaryland.edu

12. IPD Sharing Statement

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Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

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