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Novel MRI for Predicting Stroke Risk in Brain Artery Disease

Phase 4

Recruiting

Led By Sameer A Ansari, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CTA/MRA/DSA imaging findings confirm the presence of moderate to severe stenosis >50% of ≥ 1 segment of the supra-clinoid ICA, A1-A2 ACA, M1-M2 MCA, distal vertebral-basilar artery, P1-P2 PCA and complete cervical or intracranial carotid occlusions utilizing the SAMMPRIS stenosis criteria (3) Symptomatic patients defined as an association between the intracranial stenosis and perfusion/thromboembolic ischemia related symptoms of the corresponding vascular territory, based on either neurological exam (TIAs/stroke) and/or acute/subacute infarcts documented on MR-DWI within 7 days of presentation.

All symptomatic patients referred to the Stroke Neurology, Cerebrovascular Surgery, or Interventional Neuroradiology inpatient/outpatient clinical services at Northwestern University or the University of Chicago with diagnosis of intracranial atherosclerosis.

Must not have

Standard contraindications to MRI: claustrophobia, metallic implants, pacemaker, compromised kidney function (GFR < 40 ml/min), history of reaction to MRI contrast agent, history of allergic reactions to ferumoxytol or other IV iron products,

elderly patients > 85 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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]

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is evaluating the treatment of brain lesions. Different types of brain lesions will be looked at and different treatment options that have been used by the treating physicians. Investigators will grade the outcome of each treatment option based on standard of care MRI imaging.

Who is the study for?

This trial is for adults aged 18-85 with intracranial atherosclerosis confirmed by imaging, showing moderate to severe stenosis. Participants must have symptoms linked to this condition and be referred by specific clinical services at Northwestern University or the University of Chicago.

What is being tested?

The study tests Feraheme's effectiveness in predicting stroke risk in patients with ICAD using MRI. It evaluates brain lesions and treatment outcomes to determine which standard care options are most effective based on mortality and morbidity rates.

What are the potential side effects?

Potential side effects from Feraheme may include reactions at the injection site, headaches, dizziness, nausea, high blood pressure, or allergic reactions like itching or hives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe narrowing in certain brain arteries confirmed by imaging and have had symptoms or a stroke related to this.

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I have been diagnosed with intracranial atherosclerosis and am seeing a specialist at Northwestern University or the University of Chicago.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have claustrophobia, metallic implants, a pacemaker, severe kidney issues, or allergies to MRI contrast or IV iron.

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I am over 85 years old.

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I have severe narrowing in my neck or brain arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Side effects data

From 2023 Phase 2 trial • 32 Patients • NCT01336803

Allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Feraheme

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3 - Feumoxytol infusion and MRI BrainExperimental Treatment1 Intervention

An intravenous ferumoxytol infusion (before the patient leaves Northwestern or University of Chicago after stroke care or at another visit) and an MRI exam 72 hours later. This MRI examination will last approximately 30 minutes and will not involve gadavist. All arm 3 procedures will be performed either at Northwestern or University of Chicago.

Group II: Arm 2 - MRI Brain with Tc-99m-HMPAO tracerActive Control1 Intervention

This type of MRI shows the flow of blood in different areas of the brain and will be performed at University of Chicago. This is done with a tracer called Tc-99m-HMPAO, injected through a vein in the arm. HMPAO is Technetium-99m hexamethyl propylenamine oxime and used clinically to assess blood supply in the brain. This MRI will be performed one hour after the injection of this tracer at University of Chicago and will last up to one hour. A tracer is a specially designed drug that is bound to a radioactive material. Tracers are designed to act like natural products in the body allowing imaging to look at how the body is working. Tracers are designed to look at very specific organ functions and, in this case, brain.

Group III: Arm 1 - MRI Brain with CO2 inhalationActive Control1 Intervention

A research MRI exam that uses CO2 inhalation and gadavist contrast injections. This examination will last for about 45 minutes and will be performed at Northwestern. * A mask will be placed over the nose and mouth during the MRI exam. * Air mixed with CO2, and odorless, colorless gas will be delivered to the mask for breathing. * After the images are collected (approximately 5 minutes) normal air will be delivered to the mask * This scan with CO2 will last approximately 10 minutes, however the total duration of the scan will be 45 minutes as it also involves injection of gadavist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Feraheme

2011

Completed Phase 2

~100

0 / 6Eligibility criteria met