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

NCT07461948 | Recruiting Phase 3 FDA Device

• 3 other identifiers: 25-1450NCI-2025-07966KL2TR001882
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (3)

• Mean diffusion-relaxation correlation spectrum imaging (DR-CSI) value

  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

  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

  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

Study Arms (1)

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

EXPERIMENTAL

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; Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging; Procedure: Diffusion-Relaxation Correlation Spectrum Imaging; Other: Electronic Health Record Review; Drug: Ferumoxytol; Radiation: Magnetic Resonance Imaging

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging PROCEDURE

Undergo CEST MRI

Also known as: Chemical Exchange Saturation Transfer MRI

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Diffusion-Relaxation Correlation Spectrum Imaging PROCEDURE

Undergo DR-CSI

Also known as: Diffusion-Relaxation Correlation Spectroscopic Imaging, DR-CSI

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Electronic Health Record Review OTHER

Ancillary studies

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Ferumoxytol DRUG

Given IV

Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Magnetic Resonance Imaging RADIATION

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Diagnostic (CEST MRI, DR-CSI, Fe-MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Specimen Handling; Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jingwen Yao

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: March 10, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): October 27, 2028
• Study Completion (Estimated): October 27, 2028
• Last Updated: March 10, 2026

Record last verified: 2025-11

Locations

US (1)