Brain Cancer Clinical Trial
Official title:
MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI
Verified date | August 2017 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 12, 2017 |
Est. primary completion date | January 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University Hospitals and Clinics | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Michael Iv |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images. | Day 1 | ||
Secondary | Determine the number of macrophages in resected/biopsied samples at histopathology. | Days 2-4 |
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