Preclinical safety assessment of Vasovist (Gadofosveset trisodium), a new magnetic resonance imaging contrast agent for angiography

Investigative Radiology
Thomas Steger-HartmannHermann Schweinfurth

Abstract

Vasovist (EPIX Pharmaceuticals and Schering AG) is a newly developed blood pool contrast agent for magnetic resonance imaging with a high affinity for human albumin, making it an ideal tool for the detection of structural abnormalities such as stenosis and aneurysm. For the risk assessment of the single diagnostic use in patients, the toxicity of this compound was investigated. Studies of acute, repeated-dose, reproductive, and developmental toxicity as well as local tolerance, immunotoxicity, and mutagenic potential were performed. Lethality was observed in rodents after single intravenous administration at doses of at least 2 orders of magnitude higher than the anticipated human dose of 0.03 mmol/kg. The no observed adverse effect level after repeated daily administration over the course of 4 weeks to monkeys exceeded the single diagnostic dose by a factor of 3.3. The main effect of repeated dosing in both rats and monkeys was vacuolation in kidney proximal tubules without concomitant effect on kidney function. Studies into reproduction toxicity have shown no evidence of effects on fertility or perinatal and postnatal development. Signs of embryo-fetal toxicity were observed in rabbits after repeated administration of high do...Continue Reading

References

Mar 1, 1969·The Journal of Investigative Dermatology·B Magnusson, A M Kligman
Jan 1, 1995·Acta Radiologica. Supplementum·M DobrotaH Vik
Nov 1, 1996·European Journal of Radiology·S K MorcosM Dobrota
Nov 1, 2001·Topics in Magnetic Resonance Imaging : TMRI·V M Runge
Dec 21, 2004·European Radiology·Judith A W WebbUNKNOWN Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR)

❮ Previous
Next ❯

Citations

Mar 18, 2008·Biometals : an International Journal on the Role of Metal Ions in Biology, Biochemistry, and Medicine·Marc PortClaire Corot
Jan 10, 2009·Experimental and Toxicologic Pathology : Official Journal of the Gesellschaft Für Toxikologische Pathologie·T Steger-HartmannJ Walter
Jan 6, 2009·Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS·Alberto Alonso-BurgosJosé L Zubieta
Aug 19, 2015·Progress in Nuclear Magnetic Resonance Spectroscopy·Adrianus J BakermansKlaas Nicolay
Sep 30, 2009·Journal of Magnetic Resonance Imaging : JMRI·Claas P NaehleDaniel Thomas
Nov 26, 2009·Journal of Magnetic Resonance Imaging : JMRI·Jean-Marc IdéeClaire Corot
Mar 19, 2014·Magnetic Resonance Imaging·Alaa AlhadadJohan Wassélius
Oct 22, 2013·Biomaterials·Chang-Tong YangEdward G Robins
Sep 27, 2012·Investigative Radiology·Christiane WackRainer Hofmeister
Nov 14, 2006·Investigative Radiology·Val M Runge
Jan 11, 2007·Investigative Radiology·Christoph U HerbornJörg Barkhausen
Nov 17, 2007·Investigative Radiology·Olaf DöhrHermann Schweinfurth
Nov 17, 2007·Investigative Radiology·Val M Runge
May 20, 2021·Contrast Media & Molecular Imaging·Lisa C AdamsSarah Keller

❮ Previous
Next ❯

Related Concepts

Related Feeds

Aneurysm

Aneurysms are outward distensions or bulges that occurs in a weakened wall of blood vessels. Discover the latest research on aneurysms here.