Nervous System DiseasesPhase 2NCT00659776

MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

A Phase 2 study testing Ferumoxytol in people with Nervous System Diseases and Diagnostic Imaging, run by Oregon Health and Science University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Nervous System Diseases, Diagnostic Imaging
What is being tested?: Ferumoxytol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteUnited States
Study dates: Jul 2004to Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis >50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Subjects must be 18 years or older
Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
Karnofsky must be 30% or greater

Who cannot join

Subjects with clinically significant signs of uncal herniation
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 Gd contrast material.
Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
Subjects with known hepatic insufficiency or cirrhosis
Subjects with known or suspected iron overload
HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation

This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.

Conditions: Nervous System Diseases, Diagnostic Imaging
Being tested: Ferumoxytol
Keywords: ferumoxytol
Medical subject headings: Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FerumoxytolDrug
Also called Feraheme
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)

Study groups in NCT00659776
Study group	Role	What they receive
Inflammatory lesions	Active comparator	Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. Receives: Drug: Ferumoxytol
Vascular lesions	Active comparator	subjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis >50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins. Receives: Drug: Ferumoxytol
Lymph nodes	Active comparator	Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. Receives: Drug: Ferumoxytol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Lesions
Measured: 72 hours
Degree of Contrast Enhancement
Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)
Measured: 72 hours
Assessment of Border Delineation
The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).
Measured: 72hrs
Internal Morphology of Lesions
The scoring parameters were: (1=poor, 2=moderate, 3=good).
Measured: 72hrs

Secondary outcomes (3)

Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples
Measured: 72 hours
Side Effects/Safety of Ferumoxytol When Given During MRI.
Number of serious adverse events attributable to ferumoxytol.
Measured: 30 days
Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Dec 2021

First posted16 Apr 2008 (estimated)
Study startJul 2004
Primary completionDec 2020
Study completionDec 2021

Why it stopped: Due to staffing shortages and lack of funding during Covid.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659776
Sponsor's protocol ID: OHSU-1562
Other IDs: 5R01NS034608
Status last verified: Jan 2024
First submitted: 10 Apr 2008
Last updated: 30 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Nervous System Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation
ClinicalTrials.gov ID: NCT00659776
Acronym / sponsor ID: OHSU-1562
Conditions: Nervous System Diseases, Diagnostic Imaging
Keywords: ferumoxytol
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to staffing shortages and lack of funding during Covid.
Enrolment: 255 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Jul 2004 (actual)
Primary completion: Dec 2020 (actual)
Study completion: Dec 2021 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 30 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Inflammatory lesions	Active comparator	Drug: FerumoxytolSubjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.
Vascular lesions	Active comparator	Drug: Ferumoxytolsubjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis >50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins.
Lymph nodes	Active comparator	Drug: FerumoxytolSubjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis >50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Subjects must be 18 years or older
Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.

Key exclusion criteria (7 listed)

Subjects with clinically significant signs of uncal herniation
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 Gd contrast material.
Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
Subjects with known hepatic insufficiency or cirrhosis
Subjects with known or suspected iron overload

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: FerahemeFerumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)	Drug	Inflammatory lesions, Lymph nodes, Vascular lesions

Primary outcome

Number of Lesions
Time frame: 72 hours
Degree of Contrast Enhancement
Time frame: 72 hours
Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)
Assessment of Border Delineation
Time frame: 72hrs
The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).
Internal Morphology of Lesions
Time frame: 72hrs
The scoring parameters were: (1=poor, 2=moderate, 3=good).

3 secondary outcomes

Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples
Time frame: 72 hours
Side Effects/Safety of Ferumoxytol When Given During MRI.
Time frame: 30 days
Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points
Time frame: 6 months

Results and safety

Results posted to the registry on 30 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Inflammatory Lesions	230	218
Group 2: Vascular Lesions	25	23
Group 3: Lymph Nodes	0	0

Primary outcome: Number of Lesions

Time frame: 72 hours. Mean (Standard Deviation). Unit: Number of lesions

Measure	Group 1: Inflammatory Lesions n = 152	Group 2: Vascular Lesions n = 0	Group 3: Lymph Nodes n = 0
Gadolinium	1.8 (1.17)	–	–
Ferumoxytol	1.9 (1.09)	–	–

Population analysed: Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure.

Primary outcome: Degree of Contrast Enhancement

Time frame: 72 hours. Mean (Standard Deviation). Unit: Score of contrast enhancement

Measure	Group 1: Inflammatory Lesions n = 131	Group 2: Vascular Lesions n = 0	Group 3: Lymph Nodes n = 0
Gadolinium	2.9 (1.13)	–	–
Ferumoxytol	2.7 (1.13)	–	–

Primary outcome: Assessment of Border Delineation

Time frame: 72hrs. Mean (Standard Deviation). Unit: Score assessment of border delineation

Measure	Group 1: Inflammatory Lesions n = 131	Group 2: Vascular Lesions n = 0	Group 3: Lymph Nodes n = 0
Gadolinium	3.2 (.87)	–	–
Ferumoxtyol	3.2 (.75)	–	–

Primary outcome: Internal Morphology of Lesions

Time frame: 72hrs. Mean (Standard Deviation). Unit: Score of internal morphology of lesions

Measure	Group 1: Inflammatory Lesions n = 131	Group 2: Vascular Lesions n = 0	Group 3: Lymph Nodes n = 0
Gadolinium	2.4 (1.04)	–	–
Ferumoxytol	2.5 (.99)	–	–

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of ferumoxytol infusion through 30 days after ferumoxytol infusion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Inflammatory Lesions	39 of 218 (17.9%)	11 of 218 (5%)	1 of 218
Group 2: Vascular Lesions	2 of 23 (8.7%)	2 of 23 (8.7%)	0 of 23
Group 3: Lymph Nodes	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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. This study is not recruiting at the moment.

Edward A Neuwelt, MD principal investigator

Oregon Health and Science University

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 in people with Nervous System Diseases and Diagnostic Imaging, run by Oregon Health and Science University 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 6 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: stopped early, as of the sponsor's last update on 30 Jan 2024. 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?

Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Lesions (time frame: 72 hours). 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?

On the ClinicalTrials.gov record for NCT00659776.

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 30 Jan 2024.