MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

Nervous System Diseases Clinical Trial

Official title:

Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00659776
• Other study ID #: OHSU-1562
• Secondary ID: 5R01NS034608
• Status: Terminated
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: December 2021

Study information

• Verified date: January 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 255
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnostic Imaging
• Inflammation
• Nervous System Diseases

Intervention

Drug:
• Ferumoxytol
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)

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Lesions		72 hours
Primary	Degree of Contrast Enhancement	Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)	72 hours
Primary	Assessment of Border Delineation	The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).	72hrs
Primary	Internal Morphology of Lesions	The scoring parameters were: (1=poor, 2=moderate, 3=good).	72hrs
Secondary	Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples		72 hours
Secondary	Side Effects/Safety of Ferumoxytol When Given During MRI.	Number of serious adverse events attributable to ferumoxytol.	30 days
Secondary	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		6 months