MRI Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases

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:
NCT00103038
First received: February 7, 2005
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

This protocol revision seeks to expand upon the data originally collected from 12 patients who received ferumoxytol. The results of the original protocol were published in 2007 in Neurosurgery. We found that maximal ferumoxytol enhancement intensity occurred at 24 to 28 hours after administration, and the enhancing volume subsequently expanded with time into a non-gadolinium-enhancing, high T2-weighted signal region of tumor-infiltrated brain. Dynamic studies were assessed with both agents and demonstrated that gadolinium leaks out of blood vessels early after injection, whereas ferumoxytol stays intravascular in the "early" phase, thereby increasing the accuracy of tumor perfusion assessment.


Condition Intervention Phase
Brain Neoplasms
Drug: ferumoxytol
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: NCI-Sponsored Multidisciplinary Study of MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-grade Brain Tumors and/or Cerebral Metastases

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Investigate the utility of ferumoxytol and GBCA for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing DSC determined rCBV and DCE determined vascular permeability (Ktrans). [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare and evaluate MRA with ferumoxytol between different time points [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess number and size of tumors imaged [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess tumor vascularity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess histology and EM on tissue samples [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess differences in patients with prior therapy vs. no prior therapy (radiation and/or chemotherapy) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess the long term imaging characteristics of different tumors using DSC and DCE. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR imaging
ferumoxytol
Drug: ferumoxytol
Dose: 4 mg Fe/kg
Other Name: Feraheme

Detailed Description:

This protocol revision to the preliminary trial will characterize vascular properties of tumors in the CNS using ferumoxytol for DSC MRI to compare with those obtained using GBCA for DCE in a single MR imaging session. Furthermore, these imaging properties of various malignant CNS tumors will be characterized longitudinally with up to 6 imaging session over approximately 5 years. The information obtained in this study may guide the creation of a new imaging criteria to evaluate tumor progression and pseudoprogression secondary to Radiochemotherapy (RCT) in the context of wide-spread use of antiangiogenic agents. We expect that characterizing the vascular properties of tumors in the CNS using ferumoxytol for DSC MRI in order to compare with those obtained using GBCA for DCE MRI, will be achievable as in a single imaging session.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults must have either radiological or established histological diagnosis of the following general categories: high-grade glioma/CNS lymphoma or brain metastases.
  • Previously untreated patients must have a lesion on an imaging study
  • Post treatment patients will have radiographic abnormalities that may or may not be recurrent tumor
  • Patients must be 18 years or older for inclusion in this study.
  • After entry into the study, patients are expected to be followed for approximately 4-6 weeks after the final infusion of ferumoxytol.
  • All 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; or 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.
  • Pre-treatment radiological scans/studies for patients receiving ferumoxytol must be performed with approximately 16 weeks prior to study entry.

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 with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
  • Patients who are pregnant or lactating or who suspect they might be pregnant.
  • Adult patients who require monitored anesthesia for MRI scanning
  • Patients with renal insufficiency; GFR < 50.
  • 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 Gd contrast material.
  • 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.
  • Subjects with 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: NCT00103038

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
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Knight Clinical Trials Hotline    503-494-1080    trials@ohsu.edu   
Principal Investigator: Edward A Neuwelt, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Edward A. Neuwelt, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00103038     History of Changes
Obsolete Identifiers: NCT00980720
Other Study ID Numbers: OHSU-813, 3ROI CA 137488 15S1, OHSU-813, OHSU-8097, ONC-03095-LX
Study First Received: February 7, 2005
Last Updated: May 2, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
ferumoxytol
diagnostic imaging

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

ClinicalTrials.gov processed this record on October 21, 2014