Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

NCT05045027 | Active Not Recruiting Early Phase 1 FDA Device

• 2 other identifiers: 21-000514NCI-2021-08698
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Malignant Glioma; Recurrent Glioma; Recurrent Malignant Glioma

Outcome Measures

Primary Outcomes (3)

• Total sodium concentration

  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.

  Up to 5 years

• NHE1 expression

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

  Up to 5 years

• Tumor metabolism

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

  Up to 5 years

Study Arms (1)

Basic science (MRI, metabolic imaging, tissue collection)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging; Procedure: Magnetic Resonance Imaging

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of tissue samples

Also known as: Biological Sample Collection

Basic science (MRI, metabolic imaging, tissue collection)

Diagnostic Imaging PROCEDURE

Undergo multinuclear metabolic imaging

Also known as: Medical Imaging

Basic science (MRI, metabolic imaging, tissue collection)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Basic science (MRI, metabolic imaging, tissue collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

X-Rays; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Benjamin M Ellingson

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)