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

Brain Cancer Clinical Trial

Official title:

MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452216
• Other study ID #: BRNCNS0007
• Secondary ID: NCI-2015-0043526
• Status: Completed
• Phase: Early Phase 1
• First received: May 20, 2015
• Last updated: August 30, 2017
• Start date: June 10, 2015
• Est. completion date: January 12, 2017

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Injuries
• Brain Injury
• Brain Neoplasms
• Brain Tumors
• Central Nervous System Degenerative Disorder
• Central Nervous System Infections
• Central Nervous System Infectious Disorder
• Central Nervous System Vascular Malformation
• Communicable Diseases
• Congenital Abnormalities
• Disease
• Hemorrhagic Cerebrovascular Accident
• Infection
• Intracranial Hemorrhages
• Ischemic Cerebrovascular Accident
• Neurodegenerative Diseases
• Primary Brain Neoplasm
• Stroke
• Vascular Malformations

Intervention

Drug:
• Ferumoxytol
Undergo ferumoxytol-enhanced MRI

Other:
• Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Procedure:
• Magnetic Resonance Imaging
All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Michael Iv

Country where clinical trial is conducted

United States, 

Outcome

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