Clinical trial · Interventional
MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy
Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337)
- 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 pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier 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 |
|---|---|---|---|
| Adult Brain Glioblastoma | Adult Brain Glioblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion Weighted Imaging | Other | — | UNRESOLVED |
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Other | — | UNRESOLVED |
| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging | Other | — | UNRESOLVED |
| Ferumoxytol Non-Stoichiometric Magnetite | Drug | — | UNRESOLVED |
| Gadolinium | Drug | — | UNRESOLVED |
| MRI-Based Angiogram | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ferumoxytol
- description
- Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity.
- interventionNames
- Drug: Ferumoxytol Non-Stoichiometric Magnetite
- Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
- Other: Diffusion Weighted Imaging
- Other: MRI-Based Angiogram
- type
- ACTIVE_COMPARATOR
- label
- Gadoteridol
- description
- Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme * Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views * Life expectancy of greater than 6 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%) * Patients scheduled for standard therapy (6 weeks radiation therapy (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week \[w\] RT, and followed routine monthly temozolomide therapy) * Patients must be on a stable or decreasing dose (up to 8 mg daily) of dexamethasone throughout the study * After entry into the study, patients are expected to be followed for at least 1 month after the last infusion of ferumoxytol * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy * Patients may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion * Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible * Patients who require monitored anesthesia for MRI scanning * Patients with history of hemochromatosis or iron overload * Patients with renal insufficiency (glomerular filtration rate (GFR) \< 50) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ferumoxytol * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
References
Publications (0)
Data not yet available