Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    150
  • sponsor
    OHSU Knight Cancer Institute
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Updated on 14 June 2022
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Summary

This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.

Description

PRIMARY OBJECTIVES:

I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection.

SECONDARY OBJECTIVES:

I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths.

EXPLORATORY OBJECTIVES:

I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various pathologies.

II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head & neck, and liver lesions

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

After completion of study, patients are followed up at 2 and 6 weeks.

Details
Condition Central Nervous System Neoplasm, Cranial Nerve Disorder, Metastatic Malignant Neoplasm in the Brain
Treatment magnetic resonance imaging, Ferumoxytol, Gadolinium
Clinical Study IdentifierNCT03270059
SponsorOHSU Knight Cancer Institute
Last Modified on14 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects must have one of the following
Subjects must be able to undergo MRI imaging without anesthesia
Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
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
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 with a calculated glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 (Calculation must be done using the National Kidney Disease Education Program's website)
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
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