DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00978562
First received: September 16, 2009
Last updated: July 14, 2015
Last verified: July 2015
  Purpose

This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.


Condition Intervention
Childhood Brain Neoplasm
Recurrent Childhood Brain Neoplasm
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Drug: Ferumoxytol Non-Stoichiometric Magnetite
Drug: Gadolinium

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Visual and objective quantitative signal intensity [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    For the qualitative analysis, the distribution of the ranks of the image enhancement for each reviewer and the agreement of the two reviewers on the ranks of the image enhancement will be summarized.


Secondary Outcome Measures:
  • Histology (only in patients for whom a biopsy or surgery is scheduled outside of this protocol) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Appropriate descriptive statistics will be estimated.

  • Number of enhancing lesions [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Appropriate descriptive statistics will be estimated.

  • Tumor vascularity [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Appropriate descriptive statistics will be estimated.

  • Ultrastructure (only in patients for whom a biopsy or surgery is scheduled outside of this protocol) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Appropriate descriptive statistics will be estimated.

  • Volume of enhancing lesions [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Appropriate descriptive statistics will be estimated.


Estimated Enrollment: 15
Study Start Date: August 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium)
Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE-MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI
Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo DSC-MRI
Other Name: Dynamic Susceptibility Contrast-Enhanced MRI
Drug: Ferumoxytol Non-Stoichiometric Magnetite
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol
  • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
Drug: Gadolinium
Given IV
Other Names:
  • GADOLINIUM
  • Gd

Detailed Description:

PRIMARY OBJECTIVES:

I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session.

II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

SECONDARY OBJECTIVES:

I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points.

II. To describe number and size of tumors imaged. III. To assess histology and electron microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

OUTLINE:

Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.

After completion of study treatment, patients are followed up at approximately 4-6 weeks.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
  • Previously untreated participants must have a measureable lesion on an imaging study
  • Participants undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
  • Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
  • Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
  • After entry into the study, participants agree to be followed for up to 6 weeks after the final infusion of ferumoxytol
  • All participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  • Baseline MRI studies for participants receiving ferumoxytol must be performed within 16 weeks of study entry
  • 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; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria:

  • Participants with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
  • Participants with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations, are not eligible; participants with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
  • Participants who are pregnant, lactating, or who suspect they might be pregnant are not eligible
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 2.5 x upper limits of normal
  • Glomerular filtration rate (GFR) < 50
  • Participants 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 GBCA
  • Participants with known hepatic insufficiency or cirrhosis
  • Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible
  • Participants that have a known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978562

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Edward A. Neuwelt    503-494-5626    neuwelte@ohsu.edu   
Principal Investigator: Edward A. Neuwelt         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Edward Neuwelt OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00978562     History of Changes
Other Study ID Numbers: 5405, NCI-2015-00227, 1562, 2864, SOL-09064-LX, 813, 5405, P30CA069533
Study First Received: September 16, 2009
Last Updated: July 14, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Brain Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Contrast Media
Ferrosoferric Oxide
Diagnostic Uses of Chemicals
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015