Ferumoxytol for Intracranial Atherosclerosis

No longer recruiting at 1 trial location

Overseen By Adam de Havenon, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Utah

Disqualifiers: Atrial fibrillation, Kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new MRI contrast agent called ferumoxytol (an injectable product) to better understand inflammation in brain arteries affected by intracranial atherosclerosis. This condition can cause strokes, and researchers aim for ferumoxytol to enhance imaging techniques to better predict and prevent these strokes. Individuals who have experienced a stroke in the last two weeks and have significant narrowing in their brain arteries may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how ferumoxytol works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ferumoxytol, the treatment under study, is generally safe for people. In various studies, ferumoxytol has been well-tolerated. For instance, one study with 237 ferumoxytol injections given to 217 patients reported no severe or life-threatening side effects. Another study found that serious side effects were rare, with the most notable being occasional allergic reactions and low blood pressure. Severe allergic reactions, known as anaphylaxis, were extremely rare, occurring in only 0.02% to 1.3% of cases. Overall, these findings suggest that ferumoxytol is safe, though it does carry some risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ferumoxytol is unique because it offers a novel approach to treating intracranial atherosclerosis. Unlike traditional options like statins or antiplatelet drugs, which primarily focus on managing cholesterol levels or preventing blood clots, ferumoxytol uses iron oxide nanoparticles. This allows it to potentially provide clearer imaging of plaque buildup in the arteries, offering a dual benefit of treatment and enhanced diagnosis. Researchers are excited about this treatment because it could lead to more precise intervention strategies, improving patient outcomes by targeting the condition more effectively.

What evidence suggests that ferumoxytol might be an effective treatment for intracranial atherosclerosis?

Research has shown that ferumoxytol, a new MRI contrast agent, may aid in understanding intracranial atherosclerosis, a condition affecting blood vessels in the brain. This trial studies ferumoxytol's effectiveness in highlighting inflammation in blood vessel walls by accumulating in certain immune cells. This process helps researchers understand the role of inflammation in these conditions. Previous studies found it safe and effective for imaging, particularly in diagnosing heart artery problems. While primarily used for imaging, its ability to detect inflammation could be crucial for understanding and possibly treating conditions like intracranial atherosclerosis. ^{2 6 7 8 9}

Who Is on the Research Team?

Adam de Havenon, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a significant narrowing in my brain's arteries.

I had a stroke less than 14 days ago.

I had a stroke less than 14 days ago.

Exclusion Criteria

I have a documented history of atrial fibrillation.

Pregnant women

You are allergic to the contrast dye used in medical tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants receive a baseline vessel wall MRI with gadolinium contrast if not already performed as standard care

1 week

1 visit (in-person)

Follow-up MRI

Participants undergo a follow-up vessel wall MRI using ferumoxytol contrast 72-78 hours after the baseline MRI

1 week

1 visit (in-person)

Long-term Follow-up

Participants have a follow-up vessel wall MRI with gadolinium in 1 year to assess vessel wall enhancement

1 year

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ferumoxytol Injectable Product

Trial Overview 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.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

80 patients with intracranial atherosclerosis

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. withpower.com withpower.com/trial/phase-1-aneurysm-3-2017-764ab

Ferumoxytol for Intracranial Atherosclerosis ... Injectable Product will have tolerable side effects & efficacy for patients with Stroke, Intracranial Atherosclerosis, Stroke and Stroke. Learn more about the

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5505659/

Current and Potential Imaging Applications of Ferumoxytol for ... Multiple studies have reported effective and safe treatment with ferumoxytol in iron deficiency (7–9). Ferumoxytol for MR imaging. Initially, ferumoxytol was ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT03084523/

Trial | NCT03084523 A novel MRI contrast agent, ferumoxytol, allows multicontrast weighting on T1w and T2w images and provides important insight into the role of local vessel wall ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT00659776/Prot_SAP_000.pdf

NCT00659776 MR, Histologic and EM Imaging Of ... was either intracranial atherosclerosis or a specific form of hypertensive cerebral small- ... * BP and heart rate check prior to ferumoxytol and after each ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.123.015404

Diagnostic Performance and Safety of a Novel Ferumoxytol ... Ferumoxytol-enhanced CMRA demonstrated good diagnostic performance and excellent safety in the diagnosis of significant coronary stenosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4854636/

Safety and Technique of Ferumoxytol Administration for MRI Serious adverse events included hypersensitivity (2,4) and hypotension (4). The reported rates of anaphylaxis ranged from 0.02% with 2/8666 (4) to 1.3% with 1/ ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jmri.25412

MRI with ferumoxytol: A single center experience of safety ... The results of our study showed no severe, life-threatening, or fatal AEs caused by 237 ferumoxytol injections in 217 unique patients across a ...

8. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2019190477

Multicenter Safety and Practice for Off-Label Diagnostic ... Diagnostic ferumoxytol use was well tolerated, associated with no serious adverse events, and implicated in few adverse reactions. Registry ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6884068/

Multicenter Safety and Practice for Off-Label Diagnostic Use of ... The off-label diagnostic use of ferumoxytol was implicated in 83 acute adverse reactions (<2% of all injections), including hypertension, nausea, flushing, ...