Clinical trial NCT02452216: Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS
Official title: MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brain Injury
Central Nervous System Degenerative Disorder
Central Nervous System Infectious Disorder
Central Nervous System Vascular Malformation
Hemorrhagic Cerebrovascular Accident
Ischemic Cerebrovascular Accident
Primary Brain Neoplasm
Brain Cancer
Brain Tumors
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.
timeFrame: Day 1
Secondary outcomes:
measure: Determine the number of macrophages in resected/biopsied samples at histopathology.
timeFrame: Days 2-4
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Michael Iv, MD
role: PRINCIPAL_INVESTIGATOR
References: