High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multip
7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
What it found
The trial ended early for another reason (see below).
Reason given: Logistical factors affecting recruitment
What was tested
Treatment tested
- Ferumoxytol
Unknown
- Gadolinium
Diagnostic (when bound to a chelating agent)
What it measured
Main measures
Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration.
Baseline
MRI lesions
Other measures (1)
Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration.
Baseline
MRI lesions
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type. * Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.
Exclusion criteria
* Children (age \< 18) * Those who lack decision-making capability * Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia * Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions * Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level. * Pregnancy or breast feeding. * History of renal disease or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) \<40ml/min/1.73m?
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
Papers
Background
Dousset V, Brochet B, Deloire MS, Lagoarde L, Barroso B, Caille JM, Petry KG. MR imaging of relapsing multiple sclerosis patients using ultra-small-particle iron oxide and compared with gadolinium. AJNR Am J Neuroradiol. 2006 May;27(5):1000-5.Background
Vellinga MM, Oude Engberink RD, Seewann A, Pouwels PJ, Wattjes MP, van der Pol SM, Pering C, Polman CH, de Vries HE, Geurts JJ, Barkhof F. Pluriformity of inflammation in multiple sclerosis shown by ultra-small iron oxide particle enhancement. Brain. 2008 Mar;131(Pt 3):800-7. doi: 10.1093/brain/awn009. Epub 2008 Feb 1.Background
Tourdias T, Roggerone S, Filippi M, Kanagaki M, Rovaris M, Miller DH, Petry KG, Brochet B, Pruvo JP, Radue EW, Dousset V. Assessment of disease activity in multiple sclerosis phenotypes with combined gadolinium- and superparamagnetic iron oxide-enhanced MR imaging. Radiology. 2012 Jul;264(1):225-33. doi: 10.1148/radiol.12111416.Background
Daldrup-Link HE, Rydland J, Helbich TH, Bjornerud A, Turetschek K, Kvistad KA, Kaindl E, Link TM, Staudacher K, Shames D, Brasch RC, Haraldseth O, Rummeny EJ. Quantification of breast tumor microvascular permeability with feruglose-enhanced MR imaging: initial phase II multicenter trial. Radiology. 2003 Dec;229(3):885-92. doi: 10.1148/radiol.2293021045. Epub 2003 Oct 23.Background
Metz S, Lohr S, Settles M, Beer A, Woertler K, Rummeny EJ, Daldrup-Link HE. Ferumoxtran-10-enhanced MR imaging of the bone marrow before and after conditioning therapy in patients with non-Hodgkin lymphomas. Eur Radiol. 2006 Mar;16(3):598-607. doi: 10.1007/s00330-005-0045-9. Epub 2005 Nov 12.Background
Pai AB, Nielsen JC, Kausz A, Miller P, Owen JS. Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects. Clin Pharmacol Ther. 2010 Aug;88(2):237-42. doi: 10.1038/clpt.2010.80. Epub 2010 Jun 30.Background
Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.Background
Schwenk MH. Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy. 2010 Jan;30(1):70-9. doi: 10.1592/phco.30.1.70.Background
Lu M, Cohen MH, Rieves D, Pazdur R. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol. 2010 May;85(5):315-9. doi: 10.1002/ajh.21656.Background
Dousset V, Delalande C, Ballarino L, Quesson B, Seilhan D, Coussemacq M, Thiaudiere E, Brochet B, Canioni P, Caille JM. In vivo macrophage activity imaging in the central nervous system detected by magnetic resonance. Magn Reson Med. 1999 Feb;41(2):329-33. doi: 10.1002/(sici)1522-2594(199902)41:23.0.co;2-z.
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History
Started
Apr 2014
Main results due
Sept 2018
Finished
Sept 2018