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NCI-Sponsored Multidisciplinary Study of MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-grade Brain Tumors and/or Cerebral Metastases From Lung or Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Neoplasms

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Trial Information

NCI-Sponsored Multidisciplinary Study of MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-grade Brain Tumors and/or Cerebral Metastases From Lung or Breast Cancer


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 2 years. The information obtained in this study may guide the creation of a
new imaging criteria to evaluate tumor progression and pseudoprogression secondary to 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.


Inclusion Criteria:



- Adults must have either radiological or established histological diagnosis of the
following general categories: high-grade glioma/CNS lymphoma or brain metastases from
lung or breast cancer.

- 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

- If a patient needs a biopsy or neurosurgical procedure for diagnostic and/or
therapeutic purposes as necessary treatment for their disease, the scans will be
assessed and the tissue assessed by histology and/or EM for iron particles. Only
clinically indicated biopsy and/or surgery will be done and surgery is incidental to
inclusion in the protocol.

- Patients must be 18 years or older for inclusion in this study.

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

- For those patients with metastatic disease previous therapy of the primary tumor is
permitted.

- 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 approximately 4-6 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 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
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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Edward A. Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

OHSU-813

NCT ID:

NCT00103038

Start Date:

May 2009

Completion Date:

December 2013

Related Keywords:

  • Brain Neoplasms
  • ferumoxytol
  • diagnostic imaging
  • Brain Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239