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

Primary Purpose

Childhood Brain Neoplasm

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Diagnostic (ferumoxytol-enhanced MRI)
Surgery
Ferumoxytol
Tissue Analysis
Sponsored by
Michael Iv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Childhood Brain Neoplasm

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (ferumoxytol-enhanced MRI)

    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

    Iron concentration measurements
    Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.

    Secondary Outcome Measures

    Macrophages on histopathology
    Determine the number of macrophages in tissue samples at histopathology.

    Full Information

    First Posted
    June 5, 2017
    Last Updated
    April 12, 2023
    Sponsor
    Michael Iv
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03179449
    Brief Title
    In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
    Official Title
    MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Accrual Factor
    Study Start Date
    July 1, 2017 (Actual)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Michael Iv
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

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

    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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (ferumoxytol-enhanced MRI)
    Arm Type
    Experimental
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Diagnostic (ferumoxytol-enhanced MRI)
    Other Intervention Name(s)
    CONTRAST ENHANCED MRI, Contrast-enhanced MRI
    Intervention Description
    Undergo ferumoxytol-enhanced MRI
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Description
    Undergo surgical resection
    Intervention Type
    Drug
    Intervention Name(s)
    Ferumoxytol
    Other Intervention Name(s)
    Feraheme, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
    Intervention Description
    Given IV
    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.
    Primary Outcome Measure Information:
    Title
    Iron concentration measurements
    Description
    Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Macrophages on histopathology
    Description
    Determine the number of macrophages in tissue samples at histopathology.
    Time Frame
    Days 2-4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Iv
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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