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Ferumoxytol for Intracranial Atherosclerosis

Phase 1
Recruiting
Led By Adam de Havenon, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intracranial atherosclerosis (stenosis ≥50%)
Recent ischemic stroke (less than or equal to 14 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will use high-resolution MRI to study the correlation between vessel wall enhancement (a marker of inflammation) and stroke risk in patients with cerebrovascular disease.

Who is the study for?
This trial is for adults who've had a recent ischemic stroke (within the last 14 days) and have significant intracranial artery narrowing (stenosis ≥50%). It's not suitable for those under 18, with atrial fibrillation history, severe carotid stenosis (>70%), pregnancy, contrast allergies, serious kidney issues, pacemaker or MRI contraindications, iron sensitivity or high ferritin/transferrin levels.Check my eligibility
What is being tested?
The study tests Ferumoxytol Injectable Product as an MRI contrast agent to detect inflammation in brain arteries after a stroke. The goal is to understand if vessel wall enhancement on MRI can predict strokes by showing local inflammation within plaques in the brain's arteries.See study design
What are the potential side effects?
Potential side effects of Ferumoxytol include nausea, dizziness, low blood pressure reactions at injection site like swelling or pain. There may also be risks associated with its use in patients with iron overload conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a significant narrowing in my brain's arteries.
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I had a stroke less than 14 days ago.
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I had a stroke less than 14 days ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vessel Wall Enhancement with Gadolinium compared to Vessel Wall Enhancement with Ferumoxytol in intracranial atherosclerosis (ICAS) group.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
80 patients with intracranial atherosclerosis

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,609 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,241 Total Patients Enrolled
Adam de Havenon, MDPrincipal InvestigatorYale School of Medicine
2 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Ferumoxytol Injectable Product Clinical Trial Eligibility Overview. Trial Name: NCT03084523 — Phase 1
Intracranial Artery Stenosis Research Study Groups: 1
Intracranial Artery Stenosis Clinical Trial 2023: Ferumoxytol Injectable Product Highlights & Side Effects. Trial Name: NCT03084523 — Phase 1
Ferumoxytol Injectable Product 2023 Treatment Timeline for Medical Study. Trial Name: NCT03084523 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any substantial risk associated with Ferumoxytol Injectable Product?

"Ferumoxytol Injectable Product is assessed as a level 1 in terms of safety due to the fact that it has only been through one phase of clinical trial, thus limited data exists on its efficacy and safety."

Answered by AI

What is the upper limit of participants for this clinical trial?

"At this juncture, this trial is not accepting new participants. The listing was initially posted on April 26 2017 and last updated November 18 2022. Should you be searching for other trials related to stroke, there are currently 1314 such studies available while 15 studies exist concerning Ferumoxytol Injectable Product recruitment."

Answered by AI

Have any other research endeavors utilized Ferumoxytol Injectable Product?

"The initial examination of Ferumoxytol Injectable Product transpired at OHSU Knight Cancer Institute in 2014 and to date there have been 34 trials that concluded their investigations. Currently, 15 studies are running across the United States with a high concentration based out of Salt Lake City, Utah."

Answered by AI

Are there any remaining vacancies in this clinical trial?

"According to the information published on clinicaltrials.gov, this particular medical trial is not currently looking for participants. The study was initially posted in April 2017 and its last update occurred November 2022; however, there are over a thousand other trials actively recruiting now."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI
Adam de Havenon 2017. "Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03084523.
All > Atherosclerosis > Stroke
~6 spots leftby Nov 2024
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