Using Ferumoxytol-Enhanced MRI to Measure Inflammation in... | NCT02452216

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

NCT02452216

Sponsor

Michael Iv

Status

Completed

Last Update Posted

Aug 31, 2017Actual

Enrollment

10Actual

Phase

Early Phase 1

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

Interventions

Ferumoxytol
Tissue Analysis
Magnetic Resonance Imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2015-00435	Registry Identifier	CTRP (Clinical Trial Reporting Program)
26570	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2015Actual

Primary Completion Date

Jan 12, 2017Actual

Completion Date

Jan 12, 2017Actual

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

May 21, 2015

First Posted Date

May 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2017

Last Update Posted Date

Aug 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ferumoxytol	Drug	Undergo ferumoxytol-enhanced MRI	Ferumoxytol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obtain measurements of iron concentration (indicative of ferumoxytol uptake) on T2*-weighted MR images.		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Determine the number of macrophages in resected/biopsied samples at histopathology.		Days 2-4

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Iv, MD	Stanford University Hospitals and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Hospitals and Clinics		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001930	Brain Injuries
D019636	Neurodegenerative Diseases
D002494	Central Nervous System Infections
D020785	Central Nervous System Vascular Malformations
D000083302	Hemorrhagic Stroke
D000083242	Ischemic Stroke
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014947	Wounds and Injuries
D007239	Infections
D009421	Nervous System Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D020521	Stroke
D002561	Cerebrovascular Disorders
D014652	Vascular Diseases
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D052203	Ferrosoferric Oxide
D046888	Tissue Array Analysis
D009682	Magnetic Resonance Spectroscopy

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005296	Ferrous Compounds
D008903	Minerals
D046228	Microarray Analysis
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical