Status:
COMPLETED
Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Central Nervous System Lymphoma
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-gra...
Detailed Description
PRIMARY OBJECTIVES: I. Investigate the utility of ferumoxytol and gadolinium-based contrast agent (GBCA) for improved imaging biomarkers of malignant brain tumors in a single imaging session by compa...
Eligibility Criteria
Inclusion
- Subject must have either radiological or established histological diagnosis of the following general categories:
- High-grade glioma/central nervous system (CNS) lymphoma or
- Brain metastases
- Previously untreated subjects must have a lesion on an imaging study
- Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
- Subjects agree to be contacted 4-6 weeks after each study visit
- Subjects, or their legal guardian, 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-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior
Exclusion
- Subjects 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
- Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2012); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
- Subjects who are pregnant or lactating or who suspect they might be pregnant
- Subjects who require monitored anesthesia for MRI scanning
- Subjects 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 gadolinium (Gd) contrast material
- Subjects with known hepatic insufficiency or cirrhosis
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
- Subjects with three or more drug allergies from separate drug classes
Key Trial Info
Start Date :
June 4 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2016
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00103038
Start Date
June 4 2004
End Date
June 10 2016
Last Update
June 9 2022
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239