Recruiting
Phase 3

CEST, DR-CSI, Fe-MRI

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07461948

Conditions

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Diffusion-Relaxation Correlation Spectrum Imaging

Electronic Health Record Review

Ferumoxytol

Study Details

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

Study ID

NCT07461948

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Oct 27, 2028

Anticipated

Primary completion date

Oct 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Undergo CEST MRI

Diffusion-Relaxation Correlation Spectrum Imaging

Undergo DR-CSI

Electronic Health Record Review

Ancillary studies

Ferumoxytol

Given IV

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

  • Mean diffusion-relaxation correlation spectrum imaging (DR-CSI) value [ Time Frame: perioperatively/periprocedurally ]
  • Ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) measures [ Time Frame: perioperatively/periprocedurally ]
  • Chemical exchange saturation transfer (CEST) values [ Time Frame: perioperatively/periprocedurally ]

Central Contacts and Locations

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Jingwen Yao

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Mar 10, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-03-10.