Clinical trial NCT00659776: MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation
Official title: Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nervous System Diseases
Diagnostic Imaging
Keywords: ferumoxytol
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-04-16
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Lesions
timeFrame: 72 hours
measure: Degree of Contrast Enhancement
timeFrame: 72 hours
measure: Assessment of Border Delineation
timeFrame: 72hrs
measure: Internal Morphology of Lesions
timeFrame: 72hrs
Secondary outcomes:
measure: Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples
timeFrame: 72 hours
measure: Side Effects/Safety of Ferumoxytol When Given During MRI.
timeFrame: 30 days
measure: Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Edward A Neuwelt, MD
role: PRINCIPAL_INVESTIGATOR
References: