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

NCT02452216 | Completed Early Phase 1 DMC

• 3 other identifiers: BRNCNS0007NCI-2015-0043526570
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.

  Day 1

Secondary Outcomes (1)

• Determine the number of macrophages in resected/biopsied samples at histopathology.

  Days 2-4

Study Arms (1)

Ferumoxytol group

EXPERIMENTAL

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.

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

Interventions

Ferumoxytol DRUG

Undergo ferumoxytol-enhanced MRI

Also known as: Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

Ferumoxytol group

Tissue Analysis OTHER

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

Ferumoxytol group

Magnetic Resonance Imaging PROCEDURE

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Also known as: Magnetic Resonance Imaging Scan, MRI

Ferumoxytol group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Iv: lead

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Brain Injuries; Neurodegenerative Diseases; Central Nervous System Infections; Central Nervous System Vascular Malformations; Hemorrhagic Stroke; Ischemic Stroke; Brain Neoplasms

Interventions

Ferrosoferric Oxide; Tissue Array Analysis; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Infections; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Vascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Microarray Analysis; Microchip Analytical Procedures; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Michael Iv, MD

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 22, 2015
• Study Start: June 10, 2015
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)