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Trial record 17 of 25 for:    Feridex

High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases

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ClinicalTrials.gov Identifier: NCT01973517
Recruitment Status : Withdrawn (Logistical factors affecting recruitment)
First Posted : October 31, 2013
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Zeineh, Stanford University

Brief Summary:
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Feraheme Drug: Gadolinium-based contrast

Detailed Description:

Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.

In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
Study Start Date : April 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Group/Cohort Intervention/treatment
Relapsing Remitting MS
Patients with relapsing remitting multiple sclerosis will be imaged under high-field (7T) MRI prior to and following administration of gadolinium-based contrast (0.1 mmol/kg IV). Afterwards, they will be administered Feraheme 5mg/kg IV via slow push, and they will return 24 hours or later after pharmaceutical administration for post-Feraheme MR imaging.
Drug: Feraheme
Patients with relapsing remitting multiple sclerosis will be administered Feraheme 5mg/kg IV via slow push once and imaged under high-field MRI at least 24 hours following administration, to allow for adequate clearance of intravascular pharmaceutical.
Other Name: Ferumoxytol

Drug: Gadolinium-based contrast
Patients with relapsing remitting multiple sclerosis will be administered gadolinium-based contrast at a dose of 0.1 mmol/kg IV once and imaged under high-field MRI immediately following administration.
Other Name: Gadolinium




Primary Outcome Measures :
  1. Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration. [ Time Frame: Baseline ]
    Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following Feraheme administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with gadolinium-based contrast.


Secondary Outcome Measures :
  1. Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration. [ Time Frame: Baseline ]
    Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following gadolinium-based contrast administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with Ferahame.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be composed of patients with the diagnosis of relapsing remitting multiple sclerosis (MS) who are followed at the Stanford Neurosciences Clinic.
Criteria

Inclusion Criteria:

  • Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type.
  • Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.

Exclusion Criteria:

  • Children (age < 18)
  • Those who lack decision-making capability
  • Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia
  • Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions
  • Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level.
  • Pregnancy or breast feeding.
  • History of renal disease or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) <40ml/min/1.73m?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973517


Locations
United States, California
Richard M. Lucas Center for Imaging (of Stanford University)
Stanford, California, United States, 94304
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Study Director: Michael Zeineh, MD, PhD Stanford University
Study Director: Brian Rutt, PhD Stanford University

Publications:

Responsible Party: Michael Zeineh, Protocol Director, Stanford University
ClinicalTrials.gov Identifier: NCT01973517     History of Changes
Other Study ID Numbers: 27423-001
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Keywords provided by Michael Zeineh, Stanford University:
Multiple sclerosis
MRI
USPIO
Ferumoxytol
Feraheme

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Demyelinating Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions