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Research summary · AI summary · not yet reviewedHuman studyPhase 1Trial registry
Ferumoxytol in Brain MRI for Multiple Sclerosis and Healthy Volunteers
In a Phase 1 pilot study, ferumoxytol was evaluated as a safe contrast agent in brain MRI for healthy volunteers and individuals with multiple sclerosis. The safety was demonstrated by the absence of long-term signal changes, and it was found that ferumoxytol enhancement could be observed in MS lesions using a 7-tesla MRI. However, explicit results have not been reported yet.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This study explores the use of an FDA-approved drug, ferumoxytol, for improved MRI detection in multiple sclerosis, potentially enhancing imaging techniques.
What this does not prove
The study has no clear results published; it primarily aimed to assess safety and imaging techniques rather than confirm findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
Supporting passages (10)
study phasePHASE1
subjects"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.
species"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.
randomized"interventionModel": "SINGLE_GROUP",
regulatory approval details"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.
research categories"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.
intervention"description": "A 510 mg dose (17 mL) of ferumoxytol diluted in 50 mL of 0.9% normal saline will be intravenously infused over 17 minutes",
primary endpointchange in gradient-echo T2*-weighted signal in an iron-rich brain structure, the globus pallidus
findings"detailedDescription": "Objective\n\nThe goals of this pilot study are to (1) demonstrate the safety of ferumoxytol, a United States Food and Drug Administration (FDA) approved drug used in the treatment of iron deficiency anemia, as a contrast agent for brain magnetic resonance imaging (MRI), as determined by a lack of long-term signal change in healthy volunteers (HV) and people with multiple sclerosis (MS); (2) determine if ferumoxytol enhancement can be detected in MS lesions on 7-tesla (T) MRI; and (3) examine the spatial and temporal enhancement patterns of ferumoxytol compared to patterns seen with gradient-echo imaging and gadolinium contrast in MS lesions.\n\nStudy population\n\nUp to 10 HVs and up to 10 participants with MS will be recruited for this study.\n\nDesign\n\nParticipants will undergo a series of brain MRIs on a 7 T scanner.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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