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NCT Number: NCT05045027

Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease
  • AIM 1: Age 18+
  • AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade)
  • AIM 2: 10 IDH mutant and 10 IDH wild type gliomas
  • AIM 2: Clinically indicated for resective surgery or biopsy
  • AIM 2: Age 18+
  • AIM 2: Tumor size > 1x1x1 cm (measurable)
  • AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1
  • AIM 3: Age 18+

Exclusion criteria

  • AIM 1: Cannot safely perform an MRI
  • AIM 1: Age < 18
  • AIM 2: Cannot safely perform an MRI or use of MRI contrast agents
  • AIM 2: Age < 18
  • AIM 3: Cannot safely perform an MRI or use of MRI contrast agents
  • AIM 3: Age < 18

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of tissue samples

Other names: Biological Sample Collection

Diagnostic Imaging

Procedure

Undergo multinuclear metabolic imaging

Other names: Medical Imaging

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Primary outcomes

  1. Total sodium concentration

    Time frame: Up to 5 years

    Will calculate NaT using standard methodology and normalize it to ocular Na+ concentration, a constant 135 mmol/l. Will then test whether healthy tissue has a coefficient of variance (COV) of < 10% across all 20 subjects.

  2. NHE1 expression

    Time frame: Up to 5 years

    Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.

  3. Tumor metabolism

    Time frame: Up to 5 years

    Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable regression.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 16, 2021
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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