Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 1

Conditions: Glioma

Treatments: Drug: Hyperpolarized 13C-Pyruvate

Study type: Interventional

Funder types: Other

Identifiers

NCT04772456

HP-00086612

Details and patient eligibility

About

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).

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

metabolic MRI

Experimental group

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

Treatment:

Drug: Hyperpolarized 13C-Pyruvate