Central Nervous System NeoplasmPhase 2NCT03270059
Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System
A Phase 2 study testing Ferumoxytol, Gadolinium and Magnetic Resonance Imaging in people with Central Nervous System Neoplasm and Cranial Nerve Disorder, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Central Nervous System Neoplasm, Cranial Nerve Disorder, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Ferumoxytol, Gadolinium and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 15 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 metastasis, 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 informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
- Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal < 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
Who cannot join
- Subjects with clinically significant 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 hypersensitivity 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 autoimmune 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 contraindication 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Ramon Barajas, MD, 503-418-0990, barajas@ohsu.edu
Ramon Barajas, MD
About this study
Official title: The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
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:
- 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:
- 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:
- 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.
- Conditions
- Central Nervous System Neoplasm, Cranial Nerve Disorder, Metastatic Malignant Neoplasm in the Brain
- Being tested
- Ferumoxytol, Gadolinium, Magnetic Resonance Imaging
- Medical subject headings
- Central Nervous System Neoplasms, Cranial Nerve Diseases, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
GadoliniumDrug
Also called Gd
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Group I (gadolinium, ferumoxytol, MRI) | Experimental | Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. Receives: Drug: Ferumoxytol; Drug: Gadolinium; Procedure: Magnetic Resonance Imaging |
| Group II (ferumoxytol, gadolinium, MRI) | Experimental | Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1. Receives: Drug: Ferumoxytol; Drug: Gadolinium; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
Secondary outcomes (3)
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start6 Oct 2017
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Oregon Health and Science University
- Responsible party
- Principal investigator, Ramon Barajas, OHSU Knight Cancer Institute
- Investigators
- Michael F Regner, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270059
- Sponsor's protocol ID
- STUDY00017028
- Other IDs
- NCI-2017-01460, STUDY00017028
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS
- ClinicalTrials.gov ID
- NCT03270059
- Acronym / sponsor ID
- STUDY00017028
- Conditions
- Central Nervous System Neoplasm, Cranial Nerve Disorder, Metastatic Malignant Neoplasm in the Brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation, Oregon Health and Science University
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (gadolinium, ferumoxytol, MRI) | Experimental | Drug: Ferumoxytol, Drug: Gadolinium, Procedure: Magnetic Resonance ImagingPatients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. |
| Group II (ferumoxytol, gadolinium, MRI) | Experimental | Drug: Ferumoxytol, Drug: Gadolinium, Procedure: Magnetic Resonance ImagingPatients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must have one of the following:
- 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 informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
- Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal < 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
Key exclusion criteria (7 listed)
- Subjects with clinically significant 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 hypersensitivity 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 autoimmune 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 contraindication 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolAlso: Feraheme, Ferumoxytol Non-Stoichiometric MagnetiteGiven IV | Drug | Group I (gadolinium, ferumoxytol, MRI), Group II (ferumoxytol, gadolinium, MRI) |
| GadoliniumAlso: GdGiven IV | Drug | Group I (gadolinium, ferumoxytol, MRI), Group II (ferumoxytol, gadolinium, MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Group I (gadolinium, ferumoxytol, MRI), Group II (ferumoxytol, gadolinium, MRI) |
Primary outcome
Visualization of normal vasculature
Time frame: Up to 5 years
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).
Visualization of abnormal vasculature
Time frame: Up to 5 years
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).
Visualization of normal anatomical structures
Time frame: Up to 5 years
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).
Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps
Time frame: Up to 5 years
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).
3 secondary outcomes
Contrast enhancement
Time frame: Up to 5 years
Border delineation
Time frame: Up to 5 years
Internal morphology
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael F Regner, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferumoxytol, Gadolinium and Magnetic Resonance Imaging in people with Central Nervous System Neoplasm and Cranial Nerve Disorder, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy E Huddleston, MPA:HA, CCRP (5034942910, huddlesa@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of normal vasculature (time frame: Up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.