Evidence map›Paper›PMID 28495944›Full record

ArticleAJNR. American journal of neuroradiology2017

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent.

C G Varallyay, G B Toth, R Fu, J P Netto, J Firkins, P Ambady, E A Neuwelt

Open access · hybridAbstract read
In one paragraph

Article in AJNR. American journal of neuroradiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. First-in-Human Study of the Carbohydrate NanoparticleJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Trial
  3. Article
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  6. Low-field MRI: Clinical promise and challenges.Journal of magnetic resonance imaging : JMRI · 2023
    Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Topics on quantitative liver magnetic resonance imaging.Quantitative imaging in medicine and surgery · 2019
    Review
  17. Article
  18. High resolution, 3-dimensional Ferumoxytol-enhanced cardiovascular magnetic resonance venography in central venous occlusion.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2019
    Article
  19. Review
  20. Blood volume measurement using cardiovascular magnetic resonance and ferumoxytol: preclinical validation.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

C G VarallyayFrom the Departments of Radiology (C.G.V., J.P.N.).ORCID http://orcid.org/0000-0003-0640-5546
G B TothNeurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.).ORCID http://orcid.org/0000-0002-6633-3436
R FuMedical Informatics and Clinical Epidemiology (R.F.).ORCID http://orcid.org/0000-0003-4598-8211
J P NettoNeurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.).ORCID http://orcid.org/0000-0001-7157-2725
J FirkinsNeurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.).ORCID http://orcid.org/0000-0002-7803-8776
P AmbadyNeurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.).ORCID http://orcid.org/0000-0003-4812-0581
E A NeuweltNeurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.) neuwelte@ohsu.edu.ORCID http://orcid.org/0000-0002-6679-6203
Anna Needs Neuroblastoma Answers · USOregon Health & Science University · USUnited States Nuclear Regulatory Commission · USVeterans Health Administration · US

Funding

Two Compartment Models to Improve Brain Tumor TherapyR01CA137488 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI NEUWELT, EDWARD A. · 2008 to 2019
$7.3M
Opening of the Blood-Brain Barrier to Antitumor AgentsR01CA199111 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI NEUWELT, EDWARD A. · 2016 to 2020
$3.1M
Nanoparticle MR Imaging of BBB Inflammation at High Tesla in CNS TumorsR01NS053468 · NINDS · OREGON HEALTH & SCIENCE UNIVERSITY · PI NEUWELT, EDWARD A. · 2007 to 2011
$2.8M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001ENCI NIH HHS R01 CA137488NCI NIH HHS R01 CA199111NINDS NIH HHS R01 NS053468
6 · The paper itself

Abstract

background and purposeDespite the label change and the FDA's boxed warning added to the Feraheme (ferumoxytol) label in March 2015, radiologists have shown increasing interest in using ferumoxytol as an MR imaging contrast agent as a supplement or alternative to gadolinium. The goals of this study were to provide information regarding ferumoxytol safety as an imaging agent in a single center and to assess how the Feraheme label change may affect this potential, currently off-label indication. MATERIALS AND

methodsThis retrospective study evaluated the overall frequency of ferumoxytol-related adverse events when used for CNS MR imaging. Patients with various CNS pathologies were enrolled in institutional review board-approved imaging studies. Ferumoxytol was administered as multiple rapid bolus injections. The risk of adverse events was correlated with demographic data/medical history.

resultsThe safety of 671 ferumoxytol-enhanced MR studies in 331 patients was analyzed. No anaphylactic, life-threatening, or fatal (grade 4 or 5) adverse events were recorded. The overall proportion of ferumoxytol-related grade 1-3 adverse events was 10.6% (8.6% occurring within 48 hours), including hypertension (2.38%), nausea (1.64%), diarrhea (1.04%), and headache (1.04%). History of 1 or 2 allergies was associated with an increased risk of adverse events (14.61% versus 7.51% [no history];

conclusionsThe frequency of mild ferumoxytol-related adverse events was comparable with literature results, and no serious adverse event was recorded. Although the recommendations in the boxed warning should be followed, serious adverse events appear to be rare, and with proper precautions, ferumoxytol may be a valuable MR imaging agent.

Indexed as

Drug LabelingAdultAgedCentral Nervous SystemContrast MediaFemaleFerrosoferric OxideHumansInfusions, IntravenousMagnetic Resonance ImagingMaleMiddle AgedOff-Label UseRetrospective StudiesTerminology as TopicYoung AdultContrast MediaFerrosoferric Oxide

Identifiers

PMID28495944
PMCPMC5509484
OpenAlexW2613700522

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.