Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

Michael Iv

Status and phase: Completed; Early Phase 1

Conditions: Central Nervous System Infectious Disorder; Ischemic Cerebrovascular Accident; Hemorrhagic Cerebrovascular Accident; Brain Injury; Brain Tumors; Primary Brain Neoplasm; Central Nervous System Degenerative Disorder; Brain Cancer; Central Nervous System Vascular Malformation

Treatments: Drug: Ferumoxytol; Other: Tissue Analysis; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02452216

BRNCNS0007

26570 (Other Identifier)

NCI-2015-00435 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ferumoxytol group

Experimental 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.

Treatment:

Other: Tissue Analysis

Procedure: Magnetic Resonance Imaging

Drug: Ferumoxytol