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RecruitingNCT03270059Updated Sep 14, 2026

Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

A Phase 2 interventional study of Ferumoxytol and Gadolinium in Central Nervous System Neoplasm, Cranial Nerve Disorder and Metastatic Malignant Neoplasm in the Brain, sponsored by OHSU Knight Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by OHSU Knight Cancer Institute · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 547 studies in Central Nervous System Neoplasms with a site in United States — 46 open to participants now, 74 under way, 3 of them phase 3. Central Nervous System Neoplasms · United States.

Planned enrollment
42nd of 399
150 · median 31
Started
2017
with 21 others
Phase 2
170 of 547
6 open now
Primary completion
2027-12
later than 43 of 73 live
Registered
451st of 547
by date

Among the 547 studies in Central Nervous System Neoplasms with a site in United States, this one is the 42nd largest by planned enrollment of the 399 interventional ones that give a count, is one of 22 that started in 2017, is one of 170 in phase 2, reaches primary completion later than 43 of the 73 other live ones, and was the 451st registered.

Central Nervous System Neoplasms

699 studies on the registry are indexed under Central Nervous System Neoplasms; 66 are open to participants now.

Browse Central Nervous System Neoplasms studies →

Open to participants now

46 of the 547 studies in Central Nervous System Neoplasms with a site in United States are open now. Recruiting first, the newest first:

41 more — sign in →

All 46 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 57 Central Nervous System Neoplasms studies recruiting now, 35 (61%) set no upper age limit and 19 (33%) stop at 75 or younger; 35 take children under 18; 6 take healthy volunteers.

This study: 10 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.

Read the detailed description

PRIMARY OBJECTIVES:

I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection.

SECONDARY OBJECTIVES:

I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths.

EXPLORATORY OBJECTIVES:

I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various brain pathologies.

II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head \& neck, and liver lesions

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

03

Conditions studied

  • Central Nervous System Neoplasm
  • Cranial Nerve Disorder
  • Metastatic Malignant Neoplasm in the Brain
04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must have one of the following:

    • Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
    • Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
    • Neoplastic process elsewhere in the body that may affect the brain (i.e. possible , vascular compromise, treatment related changes, etc.)
  • Subjects must be able to undergo MRI imaging without anesthesia
  • Subjects must be at least 10 years of age
  • All subjects, or their legal guardians, must sign a written and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  • Sexually active women of must agree to use adequate (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; \< 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion criteria

Exclusion Criteria:

  • Subjects with signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
  • Subjects with known allergic or reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or diseases may be enrolled at the investigator's discretion
  • Subjects who are pregnant or lactating or who suspect they might be pregnant
  • Subjects who have a for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
  • Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
  • Subject who have received ferumoxytol within 3 weeks of study entry
  • Subjects with three or more drug allergies from separate drug classes
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Group I (gadolinium, ferumoxytol, MRI)

    Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

    Drug: Ferumoxytol · Drug: Gadolinium · Procedure: Magnetic Resonance Imaging

  • Experimental
    Group II (ferumoxytol, gadolinium, MRI)

    Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

    Drug: Ferumoxytol · Drug: Gadolinium · Procedure: Magnetic Resonance Imaging

Interventions

  • Given IV

    Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

  • Given IV

    Also known as: Gd

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

06

What researchers measure

Primary outcomes

  1. Visualization of normal vasculature

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% confidence interval (CI) between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

    Time frame: Up to 5 years

  2. Visualization of abnormal vasculature

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

    Time frame: Up to 5 years

  3. Visualization of normal anatomical structures

    Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

    Time frame: Up to 5 years

  4. Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps

    Will assess the confidence in identifying the lesion corresponding areas on CBV maps as well as signal change (deltaR2\*) and relative cerebral blood volume. Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).

    Time frame: Up to 5 years

Secondary outcomes

  1. Contrast enhancement

    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).

    Time frame: Up to 5 years

  2. Border delineation

    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).

    Time frame: Up to 5 years

  3. Internal morphology

    The mean difference and the associated 95% CI before versus after ferumoxytol in the three visualization variables will be estimated using a paired t-test based on the average score of the two readers. Will use the same equivalence margin of 0.4. To compare the two magnetic field strengths, will also use a linear regression model to analyze contrast to noise ratios, Image homogeneity and susceptibility artifacts (the latter two based on average score of the two readers).

    Time frame: Up to 5 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Dec 2027, 122 months after the start.

Of 50 non-industry phase 2 interventional studies under Central Nervous System Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 77. This study's planned 122 months is above that.

Counting every sponsor, half of 54 studies reached it within 58 months; a quarter within 44 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2017
First posted
Sep 1, 2017
StartActual
Oct 6, 2017
Primary completionEst.
Dec 15, 2027
CompletionEst.
Dec 15, 2028
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03270059
Responsible party
Ramon Barajas (Principal Investigator, OHSU Knight Cancer Institute) — Principal investigator
First posted
Sep 1, 2017
Start date
Oct 6, 2017
Primary completion
Dec 15, 2027 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Amy E Huddleston, MPA:HA, CCRP
Contact
huddlesa@ohsu.edu
5034942910
Lisa C Muir, MPA:HA, CCRP
Contact
bennetli@ohsu.edu
5034942910
Michael F Regner, MD
principal investigator · OHSU Knight Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Ferrosoferric Oxide · Gadolinium

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