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Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

NCT ID: NCT05045027

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-09-10

Brief Summary

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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

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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

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Glioma Malignant Glioma Recurrent Glioma Recurrent Malignant Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Basic science (MRI, metabolic imaging, tissue collection)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of tissue samples

Diagnostic Imaging

Intervention Type PROCEDURE

Undergo multinuclear metabolic imaging

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Interventions

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Biospecimen Collection

Undergo collection of tissue samples

Intervention Type PROCEDURE

Diagnostic Imaging

Undergo multinuclear metabolic imaging

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Other Intervention Names

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Biological Sample Collection Medical Imaging Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin M Ellingson

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-08698

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-000514

Identifier Type: -

Identifier Source: org_study_id