Pharmacokinetics and safety of gadobutrol-enhanced magnetic resonance imaging in pediatric patients

Investigative Radiology

Volumn 44, Issue 12, 2009, Pages 776-783

  Hahn, Gabriele ^a   Sorge, Ina ^b   Gruhn, Bernd ^c   Glutig, Katja ^a   Hirsch, Wolfgang ^b   Bhargava, Ravi ^d   Furtner, Julia ^e   Born, Mark ^f   Schröder, Cornelia ^g   Ahlström, Håkan ^h   Kaiser, Sylvie ⁱ   Moritz, Jörg Detlev ^j   Kunze, Christian Wilhelm ^k   Shroff, Manohar ^l   Stokland, Eira ^m   Trnkova, Zuzana Jirakova ⁿ   Schultze Mosgau, Marcus ⁿ   Reif, Stefanie ⁿ   Bacher Stier, Claudia ⁿ   Mentzel, Hans Joachim ^c  

^a UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^b UNIVERSITY OF LEIPZIG   (Germany)

^c JENA UNIVERSITY HOSPITAL   (Germany)

^d UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^e UNIV KLIN FÜR RADIODIAGNOSTIK   (Austria)

^f UNIVERSITY HOSPITAL BONN   (Germany)

^g Kinderradiologie   (Germany)

^h UPPSALA UNIVERSITY HOSPITAL   (Sweden)

ⁱ KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^j UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^k MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^l HOSPITAL FOR SICK CHILDREN   (Canada)

^m QUEEN SILVIA CHILDREN'S HOSPITAL   (Sweden)

ⁿ BAYER PHARMA AG   (Germany)

more..

Author keywords

Children; Gadobutrol; Magnetic resonance imaging; Population pharmacokinetics

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; GADOBUTROL;

ADOLESCENT; ARTICLE; BACKACHE; BODY WEIGHT; CHILD; CLINICAL TRIAL; CONTRAST ENHANCEMENT; CONTROLLED STUDY; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ERUPTION; DRUG EXCRETION; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; DRUG WITHDRAWAL; DYSGEUSIA; EOSINOPHILIA; FEMALE; HEADACHE; HOT FLUSH; HUMAN; LABORATORY TEST; LEUKOCYTURIA; MAGNETIC RESONANCE ANGIOGRAPHY; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MULTICENTER STUDY; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; OTITIS MEDIA; PNEUMONIA; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RESPIRATORY TRACT INFECTION; RHINOPHARYNGITIS; SCHOOL CHILD; SIDE EFFECT; UNSPECIFIED SIDE EFFECT;

EID: 73349084644     PISSN: 00209996     EISSN: 15360210     Source Type: Journal    
DOI: 10.1097/RLI.0b013e3181bfe2d2     Document Type: Article

References (30)

1. Runge VM, Muroff LR, Jinkins JR. Central nervous system: review of clinical use of contrast media. Top Magn Reson Imaging. 2001;12:231-263.
2. Runge VM, Muroff LR, Wells JW. Principles of contrast enhancement in the evaluation of brain diseases: an overview. J Magn Reson Imaging. 1997;7: 5-13.
3. Mentzel HJ, Seidel J, Fitzek C, et al. Pediatric brain MRI in neurofibromatosis type I. Eur Radiol. 2005;15:814-822.
4. Semelka RC, Helmberger TK. Contrast agents for MR imaging of the liver. Radiology. 2001;218:27-38.
5. Renken NS, Krestin GP. Magnetic resonance imaging of the kidney. Semin Ultrasound CT MR. 2005;26:153-161.
6. Reiser MF, Semmler W, Hricak H, eds. Magnetic Resonance Tomography. Berlin, Germany: Springer; 2008.
7. Zech CJ, Grazioli L, Breuer J, et al. Diagnostic performance and description of morphological features of focal nodular hyperplasia in Gd-EOB-DTPA-enhanced liver magnetic resonance imaging: results of a multicenter trial. Invest Radiol. 2008;43:504-511.
8. Green D, Parker D. CTA and MRA: visualization without catheterization. Semin Ultrasound CT MR. 2003;24:185-191.
9. Hentsch A, Aschauer MA, Balzer JO, et al. Gadobutrol-enhanced moving-table magnetic resonance angiography in patients with peripheral vascular disease: a prospective, multi-centre blinded comparison with digital subtraction angiography. Eur Radiol. 2003;13:2103-2114.
10. Hoffer FA. Magnetic resonance imaging of abdominal masses in the pediatric patient. Semin Ultrasound CT MR. 2005;26:212-223.
11. Hammerstingl R, Adam G, Ayuso JR, et al. Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a Multicenter, Double-Blind, Interindividual, Randomized Clinical Phase-III Trial. Invest Radiol. 2009;44:168-176.
12. Chooi WK, Woodhouse N, Coley SC, et al. Pediatric head and neck lesions: assessment of vascularity by MR digital subtraction angiography. AJNR. 2004;25:1251-1255.
13. Evans AL, Widjaja E, Connolly DJ, et al. Cerebral perfusion abnormalities in children with Sturge-Weber syndrome shown by dynamic contrast bolus magnetic resonance perfusion imaging. Pediatrics. 2006;117:2119-2125.
14. El-Koussy M, Lovblad KO, Steinlin M, et al. Perfusion MRI abnormalities in the absence of diffusion changes in a case of moyamoya-like syndrome in neurofibromatosis type 1. Neuroradiology. 2002;44:938-941.
15. Frenzel T, Lengsfeld P, Schirmer H, et al. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37 degrees C. Invest Radiology. 2008;43:817-828.
16. Pietsch H, Lengsfeld P, Steger-Hartmann T, et al. Impact of renal impairment on long-term retention of gadolinium in the rodent skin following the administration of gadolinium-based contrast agents. Invest Radiology. 2009; 44:226-233.
17. Staks T, Schuhmann-Giampieri G, Frenzel T, et al. Pharmacokinetics, dose proportionality, and tolerability of gadobutrol after single intravenous injection in healthy volunteers. Invest Radiology. 1994;29:709-715. (Pubitemid 24258267)
18. EMEA. Committee for medicinal products for human use (CHMP). Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population. London, United Kingdom: EMEA; 2006.
19. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Population Pharmacokinetics. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, CDER, and CBER; 1999.
20. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Draft Guidance for industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, CDER, and CBER; 1998.
21. EMEA. Committee for Proprietary Medicinal Products (CPMP). Discussion Paper on the Impact of Renal Immaturity When Investigating Medicinal Products Intended for Paediatric Use. London, United Kingdom: EMEA; 2004.
22. Brown JJ, Hynes MR, Wible JH Jr. Measurement of serum calcium concen-tration after administration of four gadolinium-based contrast agents to human volunteers. AJR. 2007;189:1539-1544.
23. Davies BE, Kozlowski K, Parker J, et al. The pharmacokinetics of multihance in pediatric subjects, a population approach. Clin Pharmacol Ther. 1999;65:139.
24. Baker JF, Kratz LC, Stevens GR, et al. Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (OptiMARK) in healthy pediatric subjects. Invest Radiol. 2004;39:334-339.
25. Wible JH Jr, Tata PN, Napoli AM, et al. Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients. Magn Reson Imaging. 2008;27:512-518.
26. Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol. 2003;17:281-299.
27. Hayton WL. Maturation and growth of renal function: dosing renally cleared drugs in children. AAPSPharmSci. 2000;2:E3.
28. Balzer JO, Loewe C, Davis K, et al. Safety of contrast-enhanced MR angiography employing gadobutrol 1.0 M as contrast material. Eur Radiol. 2003;13:2067-2074.
29. Lemke AJ, Sander B, Balzer T, etal. Safety and use of gadobutrol in patients with brain tumors (phase III trial) [in German]. Rofo. 1997;167:591-598.
30. Forsting M. Gadovist 1.0M: tolerance and clinical safety. Eur Radiol. 2008; 18(suppl 1):324-325.