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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01973517 |
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Date of registration:
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16/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
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Scientific title:
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7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01973517 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Brian Rutt, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Name:
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Michael Zeineh, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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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?
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Feraheme
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Drug: Gadolinium-based contrast
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Primary Outcome(s)
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Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration.
[Time Frame: Baseline]
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Secondary Outcome(s)
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Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration.
[Time Frame: Baseline]
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Secondary ID(s)
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27423-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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