Clinical trial · Interventional
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS
MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI
- 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 study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Injury | — | UNRESOLVED | — |
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Degenerative Disorder | — | UNRESOLVED | — |
| Central Nervous System Infectious Disorder | — | UNRESOLVED | — |
| Central Nervous System Vascular Malformation | — | UNRESOLVED | — |
| Hemorrhagic Cerebrovascular Accident | — | UNRESOLVED | — |
| Ischemic Cerebrovascular Accident | — | UNRESOLVED | — |
| Primary Brain Neoplasm | Primary Brain Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Tissue Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ferumoxytol group
- description
- All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
- interventionNames
- Drug: Ferumoxytol
- Other: Tissue Analysis
- Procedure: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.
- timeFrame
- Day 1
Secondary outcomes (1)
- measure
- Determine the number of macrophages in resected/biopsied samples at histopathology.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with suspected brain tumor diagnosed by MRI * Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases) Exclusion Criteria: * Informed consent cannot be obtained either from the patient or legal representative * Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study * Contraindication to MRI (metal implants) * Hemosiderosis/hemochromatosis * Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned) * Known hypersensitivity to Feraheme (ferumoxytol) or any of its components * Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
References
Publications (0)
Data not yet available