Novel MRI for Predicting Stroke Risk in Brain Artery Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Northwestern University
Disqualifiers: Claustrophobia, Metallic implants, Dementia, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
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.
What data supports the effectiveness of the treatment Feraheme in predicting stroke risk in brain artery disease?
Is the novel MRI for predicting stroke risk safe for humans?
How is Neurovascular Imaging different from other treatments for brain artery disease?
Neurovascular Imaging, using advanced MRI techniques, is unique because it provides a noninvasive and rapid way to assess brain function and blood flow, helping to predict stroke risk more accurately than traditional methods. Unlike other treatments, it uses diffusion-weighted and perfusion-weighted imaging to offer detailed insights into brain artery conditions without the need for invasive procedures.1112131415
Eligibility Criteria
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.Inclusion Criteria
I have severe narrowing in certain brain arteries confirmed by imaging and have had symptoms or a stroke related to this.
I have been diagnosed with intracranial atherosclerosis and am seeing a specialist at Northwestern University or the University of Chicago.
I am between 18 and 85 years old.
Exclusion 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 don't have claustrophobia, metallic implants, a pacemaker, severe kidney issues, or allergies to MRI contrast or IV iron.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
MRI Evaluation
Participants undergo various MRI scans to evaluate cerebrovascular reserve, tissue perfusion, and inflammation in ICAD plaques.
1-2 weeks
Multiple visits for MRI scans
Treatment Evaluation
Evaluation of different treatment options and outcomes based on MRI findings to stratify treatment routes.
Ongoing
Follow-up
Participants are monitored for safety and effectiveness after MRI evaluations and treatment stratification.
12 months
Treatment Details
Interventions
- Feraheme (Drug)
- Neurovascular Imaging (Other)
- Standard of Care MRI Imaging ()
- Treatment Evaluation (Other)
Trial OverviewThe 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.
Participant Groups
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 1 - MRI Brain with GadavistActive Control1 Intervention
A research MRI exam that uses the signal from a finger pulse oximeter to synchronize the MRI scan to the subjects heart beat will be acquired. The Gadavist contrast injection will be used during this MRI examination to provide images of cerebral blood flow which will serve as reference standard to identify regions of the brain compromised by cerebral vascular disease. The experimental MRI scan in this case is intended to measure the utilization of oxygen by the brain which is believed to be a predictor of future stroke. All arm 1 procedures will be performed either at Northwestern or University of Chicago.
Group III: 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
University of ChicagoCollaborator
References
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