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

• Status: Completed
• Trial end date: 2017-01-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Iv
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ferrosoferric Oxide

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