N/A
N=155
Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
Central Nervous System Lymphoma · Malignant Glioma · Metastatic Malignant Neoplasm in the Brain
Bottom Line
View on ClinicalTrials.gov: NCT00103038 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3 Tesla Magnetic Resonance Imaging (Procedure); Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure); Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging (Procedure); Ferumoxytol (Drug); Gadolinium (Drug); MRI-Based Angiogram (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans) |
— | — |
| PRIMARY Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps. |
146; 136; 39; 54 | — |
| SECONDARY Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume) |
21.71; 18.71 | — |
| SECONDARY Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity) |
1.36; 1.26 | — |
| SECONDARY Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI |
34.7; 13.4 | — |
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-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00103038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.