Using advanced MRI to image the tumor immune environment in glioblastoma

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

This project will test whether three advanced MRI methods (CEST, DR-CSI, and ferumoxytol-enhanced MRI) can noninvasively measure immune cells and proteins around glioblastoma tumors in adults preparing for surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jonsson Comprehensive Cancer Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07461948 on ClinicalTrials.gov

What this trial studies

This Phase III effort combines three MRI techniques—chemical exchange saturation transfer (CEST), diffusion-relaxation correlation spectrum imaging (DR-CSI), and ferumoxytol-enhanced MRI—to generate noninvasive measures of the tumor immune microenvironment in glioblastoma patients. Participants undergo CEST and DR-CSI at an initial research visit, receive an IV infusion of ferumoxytol, and return 24–48 hours later for ferumoxytol-enhanced MRI; blood samples and standard clinical MRIs are also collected. Imaging results will be compared with tissue obtained at planned surgical resection or biopsy and with systemic immune markers to biologically validate imaging signatures of immune cell subtypes and macrophage polarization. Patients are followed until death to link imaging measures with clinical outcomes.

Who should consider this trial

Good fit: Adults (≥18) with confirmed or suspected glioblastoma who have a measurable contrast-enhancing lesion (>1 mL) and are scheduled for standard-of-care surgical resection or biopsy and can safely undergo 3T MRI and ferumoxytol infusion are ideal candidates.

Not a fit: Patients who cannot tolerate 3T MRI, have contraindications to iron-oxide contrast (ferumoxytol), or do not have a measurable contrast-enhancing lesion are unlikely to benefit from the imaging endpoints.

Why it matters

Potential benefit: If successful, these MRI methods could provide a noninvasive way to profile the tumor immune environment, helping guide treatment decisions and reducing reliance on invasive sampling.

How similar studies have performed: Smaller clinical and preclinical studies have shown promise for CEST and iron-oxide–enhanced MRI to detect immune-related signals, but combining these techniques with DR-CSI in a large Phase III validation is relatively novel.

Eligibility criteria

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

Where this trial is running

Los Angeles, California

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Jingwen Yao — UCLA / Jonsson Comprehensive Cancer Center

Conditions Glioblastoma