MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation
Condition: Nervous System Diseases; Diagnostic Imaging
MeSH terms: Nervous System Diseases; Inflammation
Intervention: Ferumoxytol
Intervention description: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ferumoxytol

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.