Status:
TERMINATED
MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Nervous System Diseases
Diagnostic Imaging
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous s...
Eligibility Criteria
Inclusion
- Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
- Subjects must be 18 years or older
- Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
- All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
- Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
- Karnofsky must be 30% or greater
Exclusion
- Subjects with clinically significant signs of uncal herniation
- 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 allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
- Subjects with known hepatic insufficiency or cirrhosis
- Subjects with known or suspected iron overload
- HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
- Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00659776
Start Date
July 1 2004
End Date
December 1 2021
Last Update
January 30 2024
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239