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

Investigative Radiology

Volumn 41, Issue 5, 2006, Pages 449-459

  Steger Hartmann, Thomas ^a   Graham, Philip B ^b   Müller, Simone ^a   Schweinfurth, Hermann ^a  

^a BAYER PHARMA AG   (Germany)

^b EPIX Pharmaceuticals   (United States)

Author keywords

Angiography; Contrast agent; Local tolerance; Magnetic resonance imaging; Toxicity

Indexed keywords

CONTRAST MEDIUM; GADOFOSVESET; DIAGNOSTIC AGENT; GADOLINIUM; ORGANOMETALLIC COMPOUND;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; DRUG DOSE REGIMEN; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; EMBRYO; EMBRYOTOXICITY; FEMALE; FERTILITY; FETOTOXICITY; FETUS; IMMUNOTOXICITY; KIDNEY FUNCTION; KIDNEY PROXIMAL TUBULE; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; MONKEY; MOUSE; MUTAGENICITY; NEPHROTOXICITY; NONHUMAN; PERINATAL DEVELOPMENT; POSTNATAL DEVELOPMENT; PRIORITY JOURNAL; RABBIT; RAT; REPRODUCIBILITY; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; RODENT; TOXICITY TESTING; ANIMAL; CONGENITAL MALFORMATION; DOSE RESPONSE; DRUG EFFECT; DRUG SCREENING; MACACA; MOUSE STRAIN; MUTAGENESIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PREGNANCY; SPRAGUE DAWLEY RAT; WISTAR RAT;

ABNORMALITIES, DRUG-INDUCED; ANIMALS; CONTRAST MEDIA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; FEMALE; FERTILITY; FETUS; GADOLINIUM; MACACA FASCICULARIS; MAGNETIC RESONANCE IMAGING; MALE; MICE; MICE, INBRED STRAINS; MUTAGENESIS; ORGANOMETALLIC COMPOUNDS; PREGNANCY; RABBITS; RATS; RATS, SPRAGUE-DAWLEY; RATS, WISTAR;

EID: 33746741835     PISSN: 00209996     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.rli.0000208223.34203.49     Document Type: Article

References (22)

1. Zheng J, Li D, Maggioni F, et al. Single-session magnetic resonance coronary angiography and myocardial perfusion imaging using the new blood pool compound B-22956 (gadocoletic acid): initial experience in a porcine model of coronary artery disease. Invest Radiol. 2005;40:604-613.
2. Port M, Corot C, Violas X, et al. How to compare the efficiency of albumin-bound and nonalbumin-bound contrast agents in vivo: the concept of dynamic relaxivity. Invest Radiol. 2005;40:565-573.
3. Mandry D, Pedersen M, Odille F, et al. Renal functional contrast-enhanced magnetic resonance imaging: evaluation of a new rapid-clearance blood pool agent (P792) in Sprague-Dawley rats. Invest Radiol. 2005;40(9):295-305.
4. Parmelee DJ, Walovitch RC, Ouellet HS, et al. Preclinical Evaluation of the pharmacokinetics, biodistribution, and elimination of MS-325, a blood pool agent for magnetic imaging. Invest Radiol. 1997;32:741-747.
5. ICH-Harmonised Tripartite Guideline M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (Step 4), finalized in July 1997 (amended November 9, 2000). Available at: http://www.ich.org/LOB/media/MEDIA506.pdf. Accessed February 2, 2006.
6. ICH-Harmonised Tripartite Guideline S 2 B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals (Step 4), finalized in July 1997. Available at: http://www.ich.org/LOB/media/MEDIA506.pdf. Accessed February 2, 2006.
7. ICH-Harmonised Tripartite Guideline S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing) (Step 4), finalized in September 1998. Available at: http://www.ich.org/LOB/media/MEDIA497.pdf. Accessed February 2, 2006.
8. ICH-Harmonised Tripartite Guideline S5A: Detection of Toxicity to Reproduction for Medicinal Products (Step 4), finalized in June 1993. Available at: http://www.ich.org/LOB/media/MEDIA498.pdf. Accessed February 2, 2006.
9. Kilbey BJ, Nichols W, Ramel C. Handbook of Mutagenicity Test Procedures. Amsterdam: Elsevier; 1984.
10. Magnusson B, Kligman AM. The identification of contact allergens by animal assay. The guinea pig maximization test. J Invest Dermatol. 1969;52:268-276.
11. Lin JH. Species similarities and differences in pharmacokinetics. Drug Metab Dispos. 1995;23:1008-1021.
12. Schöbel C, Günzel P. Methoden und Ergebnisse toxikologischer Prüfungen von nichtionischen Röntgenkontrastmitteln. In: Peters PE, Zeitler E, eds. Röntgenkontrastmittel: Nebenwirkungen, Prophylaxe, Therapie. Berlin: Springer-Verlag; 1991:5-17.
13. Battenfeld R, Khater AER. Ioxaglate-induced light and electron microscopic alterations in the renal proximal tubular epithelium of rats. Invest Radiol. 1991;26:35-39.
14. Harpur ES, Worah D, Petter-Arnt H, et al. Preclinical safety assessment and pharmacokinetics of Gadodiamide injection, a new magnetic resonance imaging contrast agent. Invest Radiol. 1993;28:S28-S43.
15. Dobrota M, Powell CJ, Holtz E, et al. Biochemical and morphological effects of contrast media on the kidney. Acta Radiol. 1995;399(Suppl):196-203.
16. Morcos SK, Epstein FH, Haylor J, et al. Aspects of contrast media nephrotoxicity. Eur J Radiol. 1996;23:178-184.
17. Runge VM. Safety of magnetic resonance contrast media. Top Magn Reson Imag. 2001;12:309-314.
18. Tombach B, Bremer C, Reimer P, et al. Renal tolerance of a neutral gadolinium chelate (gadobutrol) in patients with chronic renal failure: results of a randomized study. Radiol. 2001;218:651-657.
19. Anonymous. Triethylenetetramine. Beratergremium für umwelt-relevante Altstoffe (BUA). vol. 89. Gesellschaft deutscher Chemiker, Frankfurt am Main; 1995.
20. Anonymous. Final report on the safety assessment of EDTA, calcium disodium EDTA, disodium EDTA, TEA-EDTA, tetrasodium EDTA, tripotassium EDTA, trisodium EDTA, HEDTA, trisodium HEDTA. Int J Toxicol. 2002;21(Suppl 2):95-142.
21. Webb AW, Thomsen HS, Morcos SK. The use of iodinated and gadolinium contrast media during pregnancy and lactation. Eur Radiol. 2005;15:1234-1240.
22. ICH-Harmonised Tripartite Guideline S 1 A.: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. 1995.