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

NCT00659776 | Terminated Phase 2 Results DMC

• 2 other identifiers: OHSU-15625R01NS034608
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervous System Diseases; Diagnostic Imaging

Keywords

ferumoxytol

Outcome Measures

Primary Outcomes (4)

• Number of Lesions

  72 hours

• Degree of Contrast Enhancement

  Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)

  72 hours

• Assessment of Border Delineation

  The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).

  72hrs

• Internal Morphology of Lesions

  The scoring parameters were: (1=poor, 2=moderate, 3=good).

  72hrs

Secondary Outcomes (3)

• Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples

  72 hours

• Side Effects/Safety of Ferumoxytol When Given During MRI.

  30 days

• 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

Study Arms (3)

Inflammatory lesions

ACTIVE COMPARATOR

Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.

Drug: Ferumoxytol

Vascular lesions

ACTIVE COMPARATOR

subjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis \>50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins.

Drug: Ferumoxytol

Lymph nodes

ACTIVE COMPARATOR

Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

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)

Also known as: Feraheme

Inflammatory lesions; Lymph nodes; Vascular lesions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Ferrosoferric Oxide

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Amy Huddleston
• Organization: Oregon Health and Science University

huddlesa@ohsu.edu

503-494-2910

Study Officials

• Edward A Neuwelt, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: July 1, 2004
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)