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MRI with Gadolinium + Ferumoxytol for Brain Conditions

Phase 2
Recruiting
Led By Michael F Regner
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be at least 10 years of age
Subjects must have neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial uses gadolinium and ferumoxytol MRI to diagnose patients with abnormalities in the central nervous system.

Who is the study for?
This trial is for individuals with brain abnormalities (tumors or other issues) who have neurological symptoms like headaches or seizures. They must be over 10 years old, able to undergo MRI without anesthesia, and not pregnant. Women of childbearing age should use contraception. Participants can't join if they have severe brain swelling signs, are pregnant/lactating, have iron overload conditions, recent ferumoxytol use, multiple drug allergies, or certain metal implants.Check my eligibility
What is being tested?
The study is testing how well two types of MRI contrast agents—gadolinium and ferumoxytol—work in diagnosing central nervous system problems. It aims to improve detection and diagnosis of brain-related health issues by comparing the effectiveness of these imaging techniques.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the contrast agents used: gadolinium or ferumoxytol. These could range from mild itching to more serious reactions like difficulty breathing. There's also a risk for those with allergies to iron-based products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 10 years old.
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I have experienced neurological symptoms like headaches or seizures.
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I can have an MRI scan without needing to be put to sleep.
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I have abnormal brain scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps
Visualization of abnormal vasculature
Visualization of normal anatomical structures
+1 more
Secondary outcome measures
Border delineation
Contrast enhancement
Internal morphology

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
9%
Hypotension
9%
Psychiatric disorders
8%
Vomiting
8%
Muscle spasms
8%
Pyrexia
7%
Arteriovenous fistula site complication
7%
Upper respiratory tract infection
7%
Fluid overload
7%
Pain in extremity
7%
Blood and lymphatic system disorders
7%
Hypertension
6%
Pruritus
6%
Hyperkalaemia
6%
Abdominal pain
6%
Cough
6%
Investigations
6%
Urinary tract infection
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Fall
4%
Acute respiratory failure
4%
Arthralgia
4%
Headache
4%
Anaemia
4%
Arteriovenous fistula thrombosis
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Mental status changes
3%
Cellulitis
2%
Hip fracture
2%
Gastrointestinal haemorrhage
2%
Angina pectoris
2%
Cardiac arrest
2%
Acute myocardial infarction
2%
Pleural effusion
2%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%
Immune system disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferumoxytol
Iron Sucrose

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (ferumoxytol, gadolinium, MRI)Experimental Treatment3 Interventions
Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.
Group II: Group I (gadolinium, ferumoxytol, MRI)Experimental Treatment3 Interventions
Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
2011
Completed Phase 4
~4380
Gadolinium
2006
Completed Phase 4
~620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
967 Previous Clinical Trials
6,845,526 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,285 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
226 Previous Clinical Trials
2,090,343 Total Patients Enrolled

Media Library

Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT03270059 — Phase 2
Brain Tumor Research Study Groups: Group I (gadolinium, ferumoxytol, MRI), Group II (ferumoxytol, gadolinium, MRI)
Brain Tumor Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT03270059 — Phase 2
Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03270059 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are included in this experiment?

"That is correct. The public clinicaltrials.gov website confirms that this research study, which was first announced on October 6th 2017, is still looking for participants. In total, they need to find 150 individuals willing to take part in the trial at a single location."

Answered by AI

Has the United States Food and Drug Administration cleared Ferumoxytol for patient use?

"Ferumoxytol's safety is based on Phase 2 trial data, which indicates that while there are no guarantees of efficacy, the medication is safe to use."

Answered by AI

Are we still looking for participants in this clinical trial?

"That is accurate, the public clinicaltrials.gov site says that this research is looking for participants. The listing was first put up on October 6th, 2017 and last updated on June 2nd, 2022. They are hoping to enrol 150 people at a single location."

Answered by AI

What other scientific investigations have included Ferumoxytol in their research?

"Currently, there are 27 trials studying the efficacy of Ferumoxytol. 4 of those studies are in Phase 3 and the rest are ongoing. Most of these trials began in Dijon but have since expanded to 69 other locations across Occitanie."

Answered by AI
~26 spots leftby Aug 2025