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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.
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have severe narrowing in certain brain arteries confirmed by imaging and have had symptoms or a stroke related to this.
Select...
I have been diagnosed with intracranial atherosclerosis and am seeing a specialist at Northwestern University or the University of Chicago.
Select...
I am between 18 and 85 years old.
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]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Side effects data
From 2023 Phase 2 trial • 32 Patients • NCT013368035%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Feraheme
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
Find a Location
Who is running the clinical trial?
University of ChicagoOTHER
1,004 Previous Clinical Trials
819,677 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,151 Total Patients Enrolled
Sameer A Ansari, MD, PhDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 85 years old.I do not have serious medical conditions or a history of drug allergies, and I am free from Alzheimer's or dementia.I have severe narrowing in certain brain arteries confirmed by imaging and have had symptoms or a stroke related to this.I don't have claustrophobia, metallic implants, a pacemaker, severe kidney issues, or allergies to MRI contrast or IV iron.I have been diagnosed with intracranial atherosclerosis and am seeing a specialist at Northwestern University or the University of Chicago.I have severe narrowing in my neck or brain arteries.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 - Feumoxytol infusion and MRI Brain
- Group 2: Arm 2 - MRI Brain with Tc-99m-HMPAO tracer
- Group 3: Arm 1 - MRI Brain with CO2 inhalation
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 55 and above able to partake in this research?
"According to the eligibility standards, individuals between 18 and 85 are eligible for this trial. Separate trials exist that cater to those under 18 or over 65 years old; 121 of them in total."
Answered by AI
Is this research actively seeking volunteers?
"The information on clinicaltrials.gov reflects that the trial is actively looking for participants, initially posted on August 16th 2021 and updated most recently on August 22nd 2022."
Answered by AI
To what extent is this research being conducted with participants?
"Affirmative. Clinicaltrials.gov contains information suggesting this clinical trial is ongoing, commencing on August 16th 2021 and last updated by August 22nd 2022. The investigation requires the enrolment of roughly 100 patients from a single site for full participation."
Answered by AI
Who is eligible to enroll in this clinical trial?
"This trial is actively recruiting 100 individuals with intracranial atherosclerosis aged between 18 and 85. In order to be eligible, the patient must have a clinical referral from either Northwestern University or The University of Chicago's Stroke Neurology, Cerebrovascular Surgery, or Interventional Neuroradiology services as well as CTA/MRA/DSA imaging evidencing >50% stenosis in at least one segment of their supra-clinoid ICA, A1-A2 ACA, M1-M2 MCA, distal vertebral-basilar artery, and P1-P2"
Answered by AI
Does Feraheme present any potential hazards to humans?
"Feraheme's safety is well-established, so it earned a score of 3. This medication has completed the fourth and final phase of clinical trials prior to approval by the appropriate regulatory body."
Answered by AI
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