Clinical trial · Interventional
Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients
Advanced MRI for Visualization and Quantification of the Tumor Immune Microenvironment (TIME) in Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Chemical Exchange Saturation Transfer Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Diffusion-Relaxation Correlation Spectrum Imaging | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Ferumoxytol | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CEST MRI, DR-CSI, Fe-MRI)
- description
- 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.
- interventionNames
- 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
Primary outcomes (3)
- measure
- Mean diffusion-relaxation correlation spectrum imaging (DR-CSI) value
- timeFrame
- perioperatively/periprocedurally
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available