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.

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.

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.

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:

(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:

See also Superparamagnetism, Superparamagnetic Contrast Agents and Classifications, Characteristics, etc..