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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03179449
Other study ID # IRB-39245
Secondary ID NCI-2017-00959PE
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date July 1, 2017
Est. completion date June 1, 2025

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
Procedure:
Surgery
Undergo surgical resection
Drug:
Ferumoxytol
Given IV
Other:
Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Michael Iv National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Iron concentration measurements Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol. Day 1
Secondary Macrophages on histopathology Determine the number of macrophages in tissue samples at histopathology. Days 2-4
See also
  Status Clinical Trial Phase
Completed NCT00978562 - DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors Early Phase 1