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

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.

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