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

About

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.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Diagnostic
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 Stats
Protocol No.
25-1450
Category
Brain Cancer
Principal Investigator
JINGWEN YAO
Contact
  • Niloofar Sheshebor
Location
  • UCLA Westwood
For Providers
NCT No.
NCT07461948
For detailed technical eligibility, visit ClinicalTrials.gov.