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Enhanced MRI Imaging for Epilepsy

Phase 2

Waitlist Available

Led By Donald Gross, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Healthy controls aged 18-64

Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan

Must not have

Weight > 127.5kg

Women of childbearing capacity with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one injection will be used while the participant is having an mri

Awards & highlights

No Placebo-Only Group

Summary

"This trial focuses on understanding temporal lobe epilepsy and how surgery can be a potential cure for patients who do not respond to medication. MRI scans of the brain can help predict surgical outcomes, with abnormalities in

Who is the study for?

This trial is for healthy individuals and those with temporal lobe epilepsy (TLE), a common type of epilepsy that often doesn't respond to medication. Participants should be interested in undergoing MRI scans using ferumoxytol, an iron supplement being tested as a contrast agent.

What is being tested?

The study tests advanced MRI techniques using ferumoxytol to better visualize blood vessels in the hippocampus—a brain area critical for TLE. The goal is to improve how we predict who will benefit from surgery by studying these small regions more clearly.

What are the potential side effects?

Ferumoxytol may cause side effects like nausea, dizziness, or skin reactions at the injection site. As it's used here as an MRI contrast agent rather than its usual role treating anemia, risks specific to this use are still being evaluated.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 64 years old and in good health.

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I am 18-64 with temporal lobe epilepsy and MRI shows my hippocampus is scarred.

Exclusion Criteria

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

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I weigh more than 127.5 kg.

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I am a woman who can have children and my pregnancy test is positive.

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I do not speak English.

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I am between 17 and 65 years old.

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I am not allergic to Feraheme or any IV iron products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one injection will be used while the participant is having an mri

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one injection will be used while the participant is having an mri

This trial's timeline: 3 weeks for screening, Varies for treatment, and one injection will be used while the participant is having an mri for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ferumoxytol enhanced cerebral vasculature imaging

Side effects data

From 2017 Phase 4 trial • 296 Patients • NCT01227616

38%

Gastrointestinal disorders

33%

Infections and infestations

31%

Injury, poisoning and procedural complications

29%

General disorders and administration site conditions

21%

Respiratory, thoracic and mediastinal disorders

20%

Musculoskeletal and connective tissue disorders

19%

Vascular disorders

18%

Nervous system disorders

16%

Metabolism and nutrition disorders

15%

Cardiac disorders

11%

Nausea

11%

Diarrhoea

10%

Skin and subcutaneous tissue disorders

Hypotension

Psychiatric disorders

Vomiting

Muscle spasms

Pyrexia

Arteriovenous fistula site complication

Upper respiratory tract infection

Fluid overload

Blood and lymphatic system disorders

Pain in extremity

Hypertension

Abdominal pain

Urinary tract infection

Cough

Hyperkalaemia

Pruritus

Investigations

Dyspnoea

Pneumonia

Sepsis

Non-cardiac chest pain

Dizziness

Acute respiratory failure

Arteriovenous fistula thrombosis

Arthralgia

Fall

Headache

Anaemia

Mental status changes

Pulmonary oedema

Cardiac failure congestive

Cellulitis

Angina pectoris

Hip fracture

Gastrointestinal haemorrhage

Cardiac arrest

Acute myocardial infarction

Pleural effusion

Cardio-respiratory arrest

Hypoglycaemia

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Immune system disorders

100%

80%

60%

40%

20%

Study treatment Arm

Ferumoxytol

Iron Sucrose

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ferumoxytol (Feraheme)Experimental Treatment1 Intervention

Each participant and control will receive Ferumoxytol (Feraheme) 4 mg/kg diluted with 60ml normal saline, administered at 150-200ml/Hr by a registered nurse using a MRI compatible IV infusion pump

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferumoxytol

2011

Completed Phase 4

~4380

0 / 7Eligibility criteria met