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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Recruitment Status : Withdrawn (Logistical factors affecting recruitment)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

Tracking Information
First Submitted Date October 16, 2013
First Posted Date October 31, 2013
Last Update Posted Date September 10, 2018
Study Start Date April 2014
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01973517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 25, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
Official Title 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Multiple Sclerosis
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Drug: Feraheme
  • Drug: Gadolinium-based contrast
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 6, 2018)
0
Original Estimated Enrollment
 (submitted: October 25, 2013)
20
Actual Study Completion Date September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility 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?
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01973517
Other Study ID Numbers 27423-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Zeineh, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Study Director: Michael Zeineh, MD, PhD Stanford University
Study Director: Brian Rutt, PhD Stanford University
PRS Account Stanford University
Verification Date September 2018