MRI Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases
Conditions
Brain Neoplasms
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
ferumoxytol, diagnostic imaging
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: ferumoxytol
Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
This protocol revision to the preliminary trial will characterize vascular properties of tumors in the central nervous system (CNS) using ferumoxytol for dynamic susceptibility contrast (DSC) MRI to compare with those obtained using gadolinium based contrast agents (GBCA) for dynamic contrast enhancement (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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 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; 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; glomerular filtration rate (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).
Location
OHSU Knight Cancer Institute
Portland, Oregon, United States
Status: Recruiting
Contact: Knight Clinical Trials Hotline - 503-494-1080 - trials@ohsu.edu
Start Date
May 2009
Completion Date
April 2020
Sponsors
OHSU Knight Cancer Institute
Source
OHSU Knight Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page