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Sinerem®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Sinerem® is the brand name (same as Combidex®) for an ultrasmall superparamagnetic iron oxide (USPIO) to detect metastatic disease in lymph nodes. Metastatic nodes show less uptake of this MRI contrast agent, which results in less signal decrease and allows the differentiation of normal lymph nodes from normal-sized, metastatic nodes.
Lymph node imaging with Sinerem® is performed 24 to 36 hours after slow infusion. Normal lymph nodes turn black post contrast, namely on T2* weighted images. Metastatic lymph nodes remain unchanged in signal intensity.
Indication and Diseases: Cancer, Imaging for diagnosis, Lymphatic disorders.
See Ferumoxtran, and Classifications, Characteristics, etc.

Guerbet decided in 2007 to withdraw its Marketing Authorisation Application (MAA) for Sinerem.
Drug Information and Specification
NAME OF COMPOUND
Ferumoxtran, USPIO, AMI-227
CENTRAL MOIETY
Fe3+/Fe2+
CONTRAST EFFECT
r1=25, r2=160, B0=0.47T, r1=23.3, r2=48.9, B0=0.47T
PHARMACOKINETIC
Vascular, lymph v. hepatocyte (AG-USPIO)
CONCENTRATION
DOSAGE
2.6 mg Fe/kg
PREPARATION
Suspend in an isotonic glucose solution
INDICATION
MR angiography vascular, staging of RES-directed liver diseases, lymph nodes
DEVELOPMENT STAGE
-
DISTRIBUTOR
PRESENTATION
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
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Further Reading:
  Basics:
The demise of Combidex - Sinerem
Wednesday, 24 March 2010   by www.wellsphere.com    
  News & More:
Ultrasmall Superparamagnetic Particles of Iron Oxide-enhanced in vivo MRI of human atherosclerotic plaques.(.pdf)
MRI Resources 
Blood Flow Imaging - Universities - MRA - Crystallography - Intraoperative MRI - Supplies
 
Combidex®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Combidex® is the brand name (same as Sinerem®) for an ultrasmall superparamagnetic iron oxide (USPIO) in the development pipeline to detect metastatic disease in lymph nodes. Metastatic lymph nodes show less uptake of this MRI contrast agent, which results in less signal decrease and allows the differentiation of normal lymph nodes from normal-sized, metastatic nodes. Combidex® has also potential to be used as a functional molecular imaging agent.
In March 2005, AMAG Pharmaceuticals Inc received an approvable letter from the U.S. Food and Drug Administration with respect to Combidex subject to certain conditions.
See also Ferumoxtran, Drug Development and Approval Process USA, Molecular Imaging and Classifications, Characteristics, etc.
Drug Information and Specification
NAME OF COMPOUND
Ferumoxtran, USPIO, AMI-227
CENTRAL MOIETY
Fe3+/Fe2+
CONTRAST EFFECT
T1, predominantly T2
r1=25, r2=160, B0=0.47T, r1=23.3, r2=48.9, B0=0.47T
PHARMACOKINETIC
Vascular, lymph v. hepatocyte (AG-USPIO)
DOSAGE
2.6 mg Fe/kg
PREPARATION
Suspend in an isotonic glucose solution
INDICATION
Lymph node, (MR angiography vascular, staging of RES-directed liver diseases)
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
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• View the DATABASE results for 'Combidex®' (6).Open this link in a new window


• View the NEWS results for 'Combidex®' (1).Open this link in a new window.
 
Further Reading:
  Basics:
The demise of Combidex - Sinerem
Wednesday, 24 March 2010   by www.wellsphere.com    
  News & More:
Combidex, MRI, and identification of nodal metastases
Wednesday, 17 June 2009   by prostatecancerinfolink.net    
Superparamagnetic Iron Oxide–enhanced MR Imaging of Head and Neck Lymph Nodes1
MRI Resources 
Sequences - Crystallography - Databases - Stimulator pool - Anatomy - Safety Training
 
FerumoxtranInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.
 
Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumoxtran is a substance of the class of ultrasmall superparamagnetic iron oxide used as a lymph node specific contrast agent for MRI.
See also Combidex®, Sinerem® and Ultrasmall Superparamagnetic Iron Oxide.
Partner(s): Cytogen Corporation, National Cancer Institute. An approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S. Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005. In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner, Guerbet SA, to the European Medicines Evaluations Agency in December 1999. (Sinerem® is the brand name for this USPIO in Europe manufactured by Guerbet, Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to AMAG Pharmaceuticals Inc.
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• View the DATABASE results for 'Ferumoxtran' (3).Open this link in a new window

 
Further Reading:
  Basics:
Superparamagnetic Iron Oxide–enhanced MR Imaging of Head and Neck Lymph Nodes1
Comparison of Two Superparamagnetic Viral-Sized Iron Oxide Particles Ferumoxides and Ferumoxtran-10 with a Gadolinium Chelate in Imaging Intracranial Tumors
2002   by www.ajnr.org    
  News & More:
Optimized Labelling of Human Monocytes with Iron Oxide MR Contrast Agents
Sunday, 30 November 2003   by rsna2003.rsna.org    
SPL Medical starts clinical trial with contrast agent ferrotran
Tuesday, 11 February 2020   by www.radboudumc.nl    
SPL Medical receives approval for Clinical Trial with contrast agent Ferrotran® in 10 top radiology centers.
Friday, 15 March 2019   by ferrotran.com    
Ultrasmall Superparamagnetic Particles of Iron Oxide-enhanced in vivo MRI of human atherosclerotic plaques.(.pdf)
MRI Resources 
Pathology - Developers - IR - Spine MRI - Knee MRI - Stimulator pool
 
Guerbet S.A.
 
www.guerbet.com/home_va.html The France-based Guerbet Group is highly specialized in contrast media for medical imaging. Its strategic goal is to be a key player in this market. Products include Dotarem (Magnetic Resonance Imaging) and Xenetix (X-ray Imaging).

MRI Contrast Agents:
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Contact Information
MAIL
Guerbet
Boite postale 50400
95943 Roissy
Charles de Gaulle Cedex
FRANCE
PHONE
+33-1-45-91-50-00
FAX
+33-1-45-91-51-99
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• View the DATABASE results for 'Guerbet S.A.' (7).Open this link in a new window


• View the NEWS results for 'Guerbet S.A.' (2).Open this link in a new window.
 
Further Reading:
  Basics:
Guerbet Completes Acquisition of Mallinckrodt’s Contrast Media and Delivery Systems Business
Sunday, 29 November 2015   by www.itnonline.com    
  News & More:
Guerbet to Spotlight Diagnostic and Interventional Solutions at the 2023 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting
Tuesday, 3 January 2023   by www.itnonline.com    
Guerbet to Spotlight the Novel New Drug Elucirem (gadopiclenol) injection at RSNA22
Saturday, 26 November 2022   by www.itnonline.com    
Guerbet receives EMA acceptance of Eluciremâ„¢ as the Brand Name for Gadopiclenol
Monday, 13 June 2022   by www.prnewswire.com    
Gadopiclenol: positive results for Phase III clinical trials
Monday, 29 March 2021   by www.pharmiweb.co    
MRI Resources 
Collections - Absorption and Emission - Claustrophobia - Manufacturers - Homepages - Patient Information
 
Superparamagnetic Iron OxideInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.
 
(SPIO) Relatively new types of MRI contrast agents are superparamagnetic iron oxide-based colloids (median diameter greater than 50nm). These compounds consist of nonstoichiometric microcrystalline magnetite cores, which are coated with dextrans (in ferumoxide) or siloxanes (in ferumoxsil). After injection they accumulate in the reticuloendothelial system (RES) of the liver (Kupffer cells) and the spleen. At low doses circulating iron decreases the T1 time of blood, at higher doses predominates the T2* effect.
SPIO agents are much more effective in MR relaxation than paramagnetic agents. Since hepatic tumors either do not contain RES cells or their activity is reduced, the contrast between liver and lesion is improved. Superparamagnetic iron oxides cause noticeable shorter T2 relaxation times with signal loss in the targeted tissue (e.g., liver and spleen) with all standard pulse sequences. Magnetite, a mixture of FeO and Fe2O3, is one of the used iron oxides. FeO can be replaced by Fe3O4.
Use of these colloids as tissue specific contrast agents is now a well-established area of pharmaceutical development. Feridex®, Endorem™, GastroMARK®, Lumirem®, Sinerem®, Resovist® and more patents pending tell us that the last word in this area is not said.
Some remarkable points using SPIO:
•
A minimum delay of about 10 min. between injection (or infusion) and MR imaging, extends the examination time.
•
Cross-section flow void in narrow blood vessels may impede the differentiation from small liver lesions.
•
Aortic pulsation artifacts become more pronounced.


See also Superparamagnetism, Superparamagnetic Contrast Agents and Classifications, Characteristics, etc..
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• View the DATABASE results for 'Superparamagnetic Iron Oxide' (32).Open this link in a new window


• View the NEWS results for 'Superparamagnetic Iron Oxide' (3).Open this link in a new window.
 
Further Reading:
  Basics:
IMAGE CONTRAST IN MRI(.pdf)
   by www.assaftal.com    
  News & More:
How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol
Saturday, 5 February 2022   by www.ncbi.nlm.nih.gov    
Polysaccharide-Core Contrast Agent as Gadolinium Alternative for Vascular MR
Monday, 8 March 2021   by www.diagnosticimaging.com    
Poly (dopamine) coated superparamagnetic iron oxide nanocluster for noninvasive labeling, tracking, and targeted delivery of adipose tissue-derived stem cells
Tuesday, 5 January 2016   by www.nature.com    
Longitudinal MRI contrast enhanced monitoring of early tumour development with manganese chloride (MnCl2) and superparamagnetic iron oxide nanoparticles (SPIOs) in a CT1258 based in vivo model of prostate cancer
Wednesday, 11 July 2012   by www.biomedcentral.com    
MRI Resources 
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