Imaging Vascular Properties of Pediatric Brain Tumors Using Ferumoxytol and Gadolinium in a Single Imaging Session

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OHSU Knight Cancer Institute
Sponsor:
Collaborators:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00978562
First received: September 16, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

Current imaging techniques often do not demonstrate the true amount and location of brain tumors, which are both critical factors for treatment decision-making. This purpose of this study is to assess the safety and effectiveness of a new iron containing agent called "ferumoxytol" in improving our ability to image pediatric brain tumors. Ferumoxytol, as well as the usual contrast agent, gadolinium, together will be used to image the blood vessels in pediatric brain tumors. After contrast agent injection into the veins, special magnetic resonance imaging (MRI) scans will be performed to see changes in blood vessels in the brain and tumor.


Condition Intervention Phase
Brain Neoplasms
Drug: ferumoxytol
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) With Ferumoxytol (Code 7228) and Dynamic Contrast-enhanced MRI (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:
  • Describe pediatric brain tumor vascular properties using ferumoxytol for DSC-MRI and gadolinium-based contrast agent (GBCA) for DCE-MRI in a single MRI session. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Describe evolving tumor vasculature imaging characteristics using DSC-MRI with ferumoxytol and DCE-MRI with GBCA. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Describe number and size of tumors imaged [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess histology and electron microscope (EM) on tissue samples [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Demonstrate differences in patients with prior therapy vs. no prior therapy (radiation and/or chemotherapy). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
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: ferumoxytol
MR imaging
Drug: ferumoxytol
Level 1 = 2mg Fe/kg Level 2 = 4mg Fe/kg
Other Name: Feraheme

Detailed Description:

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 radiologists.

  Eligibility

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

Inclusion Criteria:

  • 5-18 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 Health Insurance Portability and Accountability Act (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 (aspartate aminotransferase (AST) and/or alanine aminotransferase (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 GBCA
  • 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
  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

Contacts
Contact: Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu
Contact: Cynthia A Lacy, BSN 503-494-5626 lacyc@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Edward A Neuwelt, MD    503-494-5626    neuweltn@ohsu.edu   
Contact: Cynthia A Lacy, BSN    503-494-5626    lacyc@ohsu.edu   
Principal Investigator: Edward A Neuwelt, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00978562     History of Changes
Other Study ID Numbers: OHSU-5405, 3 RO1 CA137488 15S1, SOL-09064-LX, 5405
Study First Received: September 16, 2009
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
ferumoxytol
Diagnostic Imaging

Additional relevant MeSH terms:
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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 22, 2014