Brain Cancer, Brain Injury, Brain Tumors, Central Nervous System Degenerative Disorder, Central Nervous System Infectious Disorder, Central Nervous System Vascular Malformation, Hemorrhagic Cerebrovascular Accident, Ischemic Cerebrovascular Accident, Primary Brain Neoplasm
Conditions
Brief summary
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.
Detailed description
In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.
Interventions
DRUGFerumoxytol
Undergo ferumoxytol-enhanced MRI
OTHERTissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
PROCEDUREMagnetic Resonance Imaging
All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
Sponsors
Michael Iv
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Determine the number of macrophages in resected/biopsied samples at histopathology. | Days 2-4 |
Countries
United States
Outcome results
None listed