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Imaging Vascular Properties of Pediatric Brain Tumors Using DSC-MRI With Ferumoxytol (Code 7228) and DCE-MRI With Gadolinium in a Single Imaging Session: An NCI Sponsored Exploratory Trial

Phase 0
18 Years
Open (Enrolling)
Brain Neoplasms

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Trial Information

Imaging Vascular Properties of Pediatric Brain Tumors Using DSC-MRI With Ferumoxytol (Code 7228) and DCE-MRI With Gadolinium in a Single Imaging Session: An NCI Sponsored Exploratory Trial

Patients will be scanned at five different time-points (5 MRI series). Each patient will
have a baseline MRI study (gadolinium only, with no ferumoxytol). MRI scans with both
ferumoxytol and gadolinium contrast will be performed beginning at least 3 weeks after the
baseline scan. The timing of all MRIs will not occur more frequently than every 3 weeks,
and all five ferumoxytol/gadolinium scans will take place within 2 years from study entry.
There will be a final outpatient clinic visit approximately 1 month after the final
ferumoxytol/gadolinium MRI.

Measurements such as size of tumor, blood flow to tumor (perfusion), and leakiness of blood
vessels within the tumor (permeability) will be described at each time-point and the
information will be evaluated throughout the study. The tumor size will be evaluated by 2

Inclusion Criteria:

- ≤ 18 years of age

- radiological (presumptive) or established (proven) histological diagnosis of a brain
tumor or lesion

- previously untreated patients must have a measureable lesion on an imaging study

- Baseline MRI studies for patients receiving ferumoxytol must be performed within 6
weeks of study entry

- Patients undergoing active treatment, or who have completed treatment, will have
radiographic abnormalities that may or may not be recurrent tumor

- patients requiring surgical intervention for diagnostic and/or therapeutic purposes
as necessary for their disease are eligible

- Patients may have had prior therapy for the primary brain tumor, including surgery,
radiotherapy or chemotherapy

- agree to be followed for up to 6 weeks after the final infusion of ferumoxytol

- patients, or their legal guardians, must sign a written informed consent and HIPAA
authorization in accordance with institutional guidelines

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control;abstinence) prior to study
treatment and for the duration of study treatment

Exclusion Criteria:

- Patients with clinically significant signs of uncal herniation, such as acute
pupillary enlargement, rapidly developing motor changes (over hours), or rapidly
decreasing level of consciousness

- Patients with known allergic or hypersensitivity reactions to parenteral
iron,parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide
preparations (Ferumoxytol Investigator's Drug Brochure, 2009)

- Patients who are pregnant, lactating, or who suspect they might be pregnant

- Patients with known liver function insufficiency (AST and/or ALT greater than 2.5x
upper limits of normal) or stage IV (GFR 15-29 mL/min/1.73 m2) or stage V (GFR <15
mL/min/1.73 m2) renal insufficiency

- Subjects who have a contraindication for MRI: metal in their bodies (a cardiac
pacemaker or other incompatible device), are severely agitated, or have an allergy to

- Subjects with known hepatic insufficiency or cirrhosis

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with ferumoxytol

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Describe vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in a single MRI session. Describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Edward A Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

December 2013

Related Keywords:

  • Brain Neoplasms
  • ferumoxytol
  • Diagnostic Imaging
  • Brain Neoplasms
  • Neoplasms



Oregon Health & Science University Portland, Oregon  97201