Arm 3 - Feumoxytol infusion and MRI Brain for Intracranial Atherosclerosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Northwestern University, Chicago, IL
Intracranial Atherosclerosis+2 More
Feraheme - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The cerebral and spinal vasculature possesses several unique properties: it is composed of relatively small vessels, it has a highly connected network architecture, and, due to the confined space around the brain, disruptions in flow (rupture, shunting, or blockage) can cause a clinical impact quickly. These features apply across various pathological conditions that alter the distribution of blood through the cerebral vasculature, such as aneurysm, intracranial atherosclerotic disease (ICAD) and arteriovenous malformation (AVM) as well as others. Neurovascular disease is a leading cause of mortality due to stroke in the United States and encompasses a broad range of pathologies including but not limited to cerebral arteriovenous malformation, intracranial atherosclerotic disease, intracranial aneurysms and other neurovascular abnormalities. Novel modalities for assessing disease states in patients with these pathologic conditions are constantly being developed and the understanding of risk factors, disease progression, and effective therapy is rapidly evolving. Neurovascular imaging is at the forefront of this progress. The identification of new predictive biomarkers regarding the risk of rupture, progression, or recurrence will improve prognosis and treatment planning. In this study, there will be evaluation of the various types of brain lesions and different treatment options that have been used by the treating physicians and, grade outcome based on the standard of care MRI imaging. This can help the Investigators stratify the treatment routes, that are better than the other by assessing the mortality and morbidity rates. Investigators are evaluating intracranial lesions and their treatment outcomes can help analyze which standard of care treatment is better than the others at a setting like Northwestern.

Eligible Conditions

  • Intracranial Atherosclerosis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Intracranial Atherosclerosis

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: one year - We are not using clinical endpoints, it is a developmental and pilot feasibility study of novel MRI applications to assess MR OEF/CVR, using quantitative MR PWI as marker of disease severity]

one year - We are not using clinical endpoints, it is a developmental and pilot feasibility study of novel MRI applications to assess MR OEF/CVR, using quantitative MR PWI as marker of disease severity]

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Intracranial Atherosclerosis

Side Effects for

Feraheme
5%Allergic reaction
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01336803) in the Feraheme ARM group. Side effects include: Allergic reaction with 5%.

Trial Design

3 Treatment Groups

Arm 1 - MRI Brain with CO2 inhalation
1 of 3
Arm 2 - MRI Brain with Tc-99m-HMPAO tracer
1 of 3
Arm 3 - Feumoxytol infusion and MRI Brain
1 of 3
Active Control
Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Arm 3 - Feumoxytol infusion and MRI Brain · No Placebo Group · Phase 4

Arm 3 - Feumoxytol infusion and MRI Brain
Drug
Experimental Group · 1 Intervention: Feraheme · Intervention Types: Drug
Arm 1 - MRI Brain with CO2 inhalationNoIntervention Group · 1 Intervention: Arm 1 - MRI Brain with CO2 inhalation · Intervention Types:
Arm 2 - MRI Brain with Tc-99m-HMPAO tracerNoIntervention Group · 1 Intervention: Arm 2 - MRI Brain with Tc-99m-HMPAO tracer · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Feraheme
2011
Completed Phase 2
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year - we are not using clinical endpoints, it is a developmental and pilot feasibility study of novel mri applications to assess mr oef/cvr, using quantitative mr pwi as marker of disease severity]

Trial Background

Prof. Sameer A. Ansari, Professor of Radiology
Principal Investigator
Northwestern University
Closest Location: Northwestern University · Chicago, IL
Photo of Northwestern University  1Photo of Northwestern University  2Photo of Northwestern University  3
1993First Recorded Clinical Trial
1 TrialsResearching Intracranial Atherosclerosis
1040 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the study if you are between the ages of 18 and 85 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.