NCT05045027

Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.

Detailed description

PRIMARY OBJECTIVES: I. Construct and test a novel multinuclear Na+-H+ metabolic MRI sequence with sensitivity to Sodium (Na+) concentration, Potential of Hydrogen (pH), and oxygen (O2). II. Correlate Na+-, pH-, and O2-weighted MR image measurements with sodium-proton exchanger isoform-1 (NHE1) immunohistochemistry (IHC), bioenergetics, and gene expression using stereotactic image-guided biopsies from human brain tumors. III. Quantify changes in Na+-, pH-, and O2-weighted MR images after neoadjuvant anti-PD-1 immunotherapy in recurrent glioblastoma (GBM) and explore associated changes in tumor biology. OUTLINE: AIM 1: Previous scan data from healthy subjects is collected and analyzed. AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis. AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.

Conditions

• Glioma
• Malignant Glioma
• Recurrent Glioma
• Recurrent Malignant Glioma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tissue samples
PROCEDURE	Diagnostic Imaging	Undergo multinuclear metabolic imaging
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-09-10
• Completion: 2027-09-10
• First posted: 2021-09-16
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study