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

Primary Purpose

Brain Injury, Central Nervous System Degenerative Disorder, Central Nervous System Infectious Disorder

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ferumoxytol

Tissue Analysis

Magnetic Resonance Imaging

About this trial

This is an interventional diagnostic trial for Brain Injury

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Stanford University Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ferumoxytol group

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02452216

First Posted

May 20, 2015

Last Updated

August 30, 2017

Sponsor

Michael Iv

1. Study Identification

Unique Protocol Identification Number

NCT02452216

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 10, 2015 (Actual)

Primary Completion Date

January 12, 2017 (Actual)

Study Completion Date

January 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Iv

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferumoxytol group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ferumoxytol

Other Intervention Name(s)

Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

Intervention Description

Undergo ferumoxytol-enhanced MRI

Intervention Type

Other

Intervention Name(s)

Tissue Analysis

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

Magnetic Resonance Imaging Scan, MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

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

Time Frame

Days 2-4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Iv, MD

Organizational Affiliation

Stanford University Hospitals and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Hospitals and Clinics

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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