Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

Phase 1

Recruiting

• Conditions: Glioma
• Interventions: Drug: Hyperpolarized 13C-Pyruvate

• Registration Number: NCT04772456
• Lead Sponsor: University of Maryland, Baltimore

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
metabolic MRI	Hyperpolarized 13C-Pyruvate	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

Primary Outcome Measures

Name	Time	Method
Accuracy of metabolic MRI to diagnose Glioma	Within three years post treatment	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

Name	Time	Method
Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer	Within three years post treatment	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.

Trial Locations

Locations (1)

Rosy Njonkou Tchoquessi; 🇺🇸 Baltimore, Maryland, United States