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In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

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ClinicalTrials.gov Identifier: NCT03179449
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Iv, Stanford University

Brief Summary:
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.

Condition or disease Intervention/treatment Phase
Childhood Brain Neoplasm Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI) Procedure: Surgery Drug: Ferumoxytol Other: Tissue Analysis Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.

SECONDARY OBJECTIVES:

I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.

OUTLINE:

Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: Diagnostic (ferumoxytol-enhanced MRI)
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.
Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Procedure: Surgery
Undergo surgical resection

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

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




Primary Outcome Measures :
  1. Iron concentration measurements [ Time Frame: Day 1 ]
    Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.


Secondary Outcome Measures :
  1. Macrophages on histopathology [ Time Frame: Days 2-4 ]
    Determine the number of macrophages in tissue samples at histopathology.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection

Exclusion Criteria:

  • Informed consent cannot be obtained either from the patient or legal representative
  • Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
  • Contraindication to MRI (metal implants)
  • Hemosiderosis/hemochromatosis
  • 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
  • Known hypersensitivity to ferumoxytol or any of its components
  • Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179449


Contacts
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Contact: Vyvian Ngo 408-890-9777 vyviann@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Paymon Rezaii    650-743-8336    prezaii@stanford.edu   
Principal Investigator: Michael Iv         
Sponsors and Collaborators
Michael Iv
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Iv Stanford University
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Responsible Party: Michael Iv, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03179449    
Other Study ID Numbers: IRB-39245
NCI-2017-00959 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PEDSBRNCNS0008 ( Other Identifier: Stanford Cancer Institute )
P30CA124435 ( U.S. NIH Grant/Contract )
PEDSBRNCNS0008 ( Other Identifier: OnCore )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions