Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients

March 6, 2026 updated by: Jonsson Comprehensive Cancer Center

Advanced MRI for Visualization and Quantification of the Tumor Immune Microenvironment (TIME) in Glioblastoma

This phase III trial is evaluating whether a combination of three advanced magnetic resonance imaging (MRI) techniques, including chemical exchange saturation transfer (CEST) MRI, diffusion-relaxation correlation spectrum imaging (DR-CSI), and ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) are effective as non-invasive methods for assessing the cells and proteins that surround and interact with tumor cells (the tumor immune microenvironment) in patients with glioblastoma. Researchers understand that some types of brain tumors are harder to treat than others, but the reasons for this are not known in many cases. CEST MRI uses differences in the tissue microenvironment, like protein concentration or intracellular pH, to generate contrast differences. DR-CSI detects microstructural changes in tissue associated with immune cells infiltrating the tumor. Fe-MRI uses ferumoxytol as a contrast agent with MRI. Contrast agents are substances that are injected into the body and taken up by certain tissues, making the tissues easier to see in imaging scans. More advanced imaging techniques like CEST, DR-CSI, and Fe-MRI may offer less invasive methods than surgery or biopsy for helping researchers understand the tumor immune microenvironment in patients with glioblastoma, which may help researchers determine why some tumors are more resistant to treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To establish the biological validation of advanced MRI as a non-invasive imaging modality for assessing the tumor immune microenvironment (TIME) in glioma.

SECONDARY OBJECTIVES:

I. Conduct more detailed correlation explorations focusing on relevant subpopulations, such as cluster of differentiation 4 (CD4+) versus ( cluster of differentiation 8 (CD8+) T cells and M1- versus M2-like tumor-associated macrophages (TAMs).

II. Perform exploratory correlation analysis between tumor-averaged imaging measures with systemic immunological markers (T cell activation and interferon pathway signaling), to improve our understanding of the relationship between local tissue immune environment and systemic immune response in glioma patients.

OUTLINE:

Patients undergo research CEST MRI and DR-CSI over 30 minutes at research visit 1, up to 28 days before standard of care surgery/biopsy. Following research CEST MRI and DR-CSI at research visit 1, patients receive ferumoxytol intravenously (IV) over 10-15 minutes. Approximately 24-48 hours later, patients undergo Fe-MRI over 15 minutes at research visit 2. Patients also undergo standard of care clinical MRI and collection of blood samples on study.

After completion of study intervention, patients are followed up until death.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jingwen Yao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Documentation of a confirmed or suspected diagnosis of glioblastoma
  • The participant is scheduled to undergo standard of care surgical tumor resection and/or biopsy
  • The participant has a measurable contrast-enhancing lesion (> 1ml) based on the most recent MRI prior to resection/biopsy

Exclusion Criteria:

  • Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
  • Individuals who cannot tolerate MRI scan, or with contraindication to 3-Tesla (3T) MRI
  • Any abnormalities that would be a contraindication to iron-oxide nanoparticle-based contrast agent. Medical history will be gathered from the patient and clinical chart. The information will be reviewed with medical professionals (Doctor of Medicine [MD]) to determine the eligibility of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (CEST MRI, DR-CSI, Fe-MRI)
Patients undergo research CEST MRI and DR-CSI over 30 minutes at research visit 1, up to 28 days before standard of care surgery/biopsy. Following research CEST MRI and DR-CSI at research visit 1, patients receive ferumoxytol IV over 10-15 minutes. Approximately 24-48 hours later, patients undergo Fe-MRI over 15 minutes at research visit 2. Patients also undergo standard of care clinical MRI and collection of blood samples on study.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol Non-Stoichiometric Magnetite
Other: Electronic Health Record Review
Ancillary studies
Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
Undergo CEST MRI
Other Names:
  • Chemical Exchange Saturation Transfer MRI
Procedure: Diffusion-Relaxation Correlation Spectrum Imaging
Undergo DR-CSI
Other Names:
  • Diffusion-Relaxation Correlation Spectroscopic Imaging
  • DR-CSI
Radiation: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean diffusion-relaxation correlation spectrum imaging (DR-CSI) value
Time Frame: perioperatively/periprocedurally
Mean DR-CSI values will be correlated with T cell densities. Pearson's or Spearman's correlation coefficients will be used depending on variable distributions.
perioperatively/periprocedurally
Ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) measures
Time Frame: perioperatively/periprocedurally
Fe-MRI measures will be correlated with tumor-associated macrophage densities and iron staining concentration. Pearson's or Spearman's correlation coefficients will be used depending on variable distributions.
perioperatively/periprocedurally
Chemical exchange saturation transfer (CEST) values
Time Frame: perioperatively/periprocedurally
CEST values will be correlated with tumor burden and immune suppression markers. Pearson's or Spearman's correlation coefficients will be used depending on variable distributions.
perioperatively/periprocedurally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Jingwen Yao, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2025

Primary Completion (Estimated)

October 27, 2028

Study Completion (Estimated)

October 27, 2028

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1450
  • NCI-2025-07966 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • KL2TR001882 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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