Using gadolinium and ferumoxytol MRI to diagnose central nervous system abnormalities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of gadolinium and ferumoxytol magnetic resonance imaging (MRI) in diagnosing abnormalities in the central nervous system. The study aims to determine how prior gadolinium administration influences vascular imaging with ferumoxytol and to assess signal changes in T2*w multi-echo fast field echo scans before and after contrast agent injection. Patients will be randomized into two groups to receive either gadolinium followed by ferumoxytol or vice versa, with MRI conducted over a 60-minute period. Secondary and exploratory objectives include evaluating the effects of ferumoxytol on gadolinium-enhanced MRI and exploring late enhancement in various brain pathologies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects must have one of the following:

  * Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
  * Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
  * Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)
* Subjects must be able to undergo MRI imaging without anesthesia
* Subjects must be at least 10 years of age
* All subjects, 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 must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal \< 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

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, 2009); 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 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 containing contrast material
* Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
* Subject who have received ferumoxytol within 3 weeks of study entry
* Subjects with three or more drug allergies from separate drug classes

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Michael F Regner, MD — OHSU Knight Cancer Institute
• Study coordinator: Amy E Huddleston, MPA:HA, CCRP
• Email: huddlesa@ohsu.edu
• Phone: 5034942910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.