The safety and efficacy of neuroimaging with gadoversetamide injection in pediatric patients

Current Medical Research and Opinion

Volumn 22, Issue 12, 2006, Pages 2515-2524

  Lowe, Lisa H ^a   Kearns, Gregory L ^a   Wible Jr , James H ^b  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^b MALLINCKRODT PHARMACEUTICALS   (United States)

Author keywords

Adverse events; Clinical trial; Contrast media; Gadoversetamide; Magnetic resonance imaging; Neuroimaging; Pediatrics

Indexed keywords

GADOVERSETAMIDE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; ANEMIA; ARTICLE; BLEEDING; CENTRAL NERVOUS SYSTEM; CHILD; COLD SENSATION; CONTRAST ENHANCEMENT; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYSTITIS; DIAGNOSTIC ACCURACY; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; EAR DISEASE; ECG ABNORMALITY; ELECTROCARDIOGRAPHY; EOSINOPHILIA; ERYTHEMA; EXTRAVASATION; FEMALE; HEADACHE; HEMATOCRIT; HEMATURIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPERPHOSPHATEMIA; HYPERURICEMIA; HYPOCALCEMIA; HYPOMAGNESEMIA; HYPOPROTEINEMIA; INJECTION SITE REACTION; IRON BLOOD LEVEL; LABORATORY TEST; LOCAL SKIN REACTION; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MUSCLE SPASM; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; PHYSICAL EXAMINATION; QT PROLONGATION; RASH; RHINITIS; SEDATION; SENSITIVITY AND SPECIFICITY; SIDE EFFECT; SINGLE DRUG DOSE; VITAL SIGN; VOMITING; ZINC BLOOD LEVEL; ZINC URINE LEVEL;

ADOLESCENT; CENTRAL NERVOUS SYSTEM DISEASES; CHILD; CHILD, PRESCHOOL; CONTRAST MEDIA; ELECTROCARDIOGRAPHY; FEMALE; HEART; HUMANS; INJECTIONS, INTRAVENOUS; MAGNETIC RESONANCE IMAGING; MALE; ORGANOMETALLIC COMPOUNDS; SENSITIVITY AND SPECIFICITY;

EID: 33846026324     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X159452     Document Type: Article

References (20)

1. Kirchin MA, Runge VM. Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging 2003;14:426-35
2. Runge VM. Safety of magnetic resonance contrast media. Top Magn Reson Imaging 2001;12:309-14
3. Grossman R, Kuhn MJ, Maravilla K, et al. Multicenter evaluation of the safety, tolerance, and efficacy of OptiMARK in magnetic resonance imaging of the brain and spine. Acad Radiol 1998;5(Suppl 1):S154-6
4. Runge VM, Bradley WG, Brant-Zawadzki MN, et al. Clinical safety and efficacy of gadoteridol: a study in 411 patients with suspected intracranial and spinal disease. Radiology 1991;181:701-9
5. Sze G, Brant-Zawadzki M, Haughton VM, et al. Multicenter study of gadodiamide injection as a contrast agent in MR imaging of the brain and spine. Radiology 1991;181:693-9
6. 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;39:334-9
7. Grossman RI, Rubin DL, Hunter G, et al. Magnetic resonance imaging in patients with central nervous system pathology: a comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA). Invest Radiol 2000;35:412-9
8. Powers TA, Partain CL, Kessler RM, et al. Central nervous system lesions in pediatric patients: Gd-DTPA-enhanced MR imaging. Radiology 1988;169:723-6
9. Elster AD, Rieser GD. Gd-DTPA-enhanced cranial MR imaging in children: initial clinical experience and recommendations for its use. AJR 1989;153:1265-8
10. Elster AD. Cranial MR imaging with Gd-DTPA in neonates and young infants: preliminary experience. Radiology 1990;176:225-30
11. Lundby B, Gordon P, Hugo F. MRI in children given gadodiamide injection: safety and efficacy in CNS and body indications. Eur J Radiol 1996;23:190-6
12. Ball WS Jr, Nadel SN, Zimmerman RA, et al. Phase III multicenter clinical investigation to determine the safety and efficacy of gadoteridol in children suspected of having neurologic disease. Radiology 1993;186:769-74
13. Brown JJ, Kristy RM, Stevens GR, et al. The OptiMARK clinical development program: summary of safety data. J Magn Reson Imaging 2002;15:446-55
14. Puttagunta NR, Gibby WA, Smith GT. Human in vivo comparative study of zinc and copper transmetallation after administration of magnetic resonance imaging contrast agents. Invest Radiol 1996;31:739-42
15. Kimura J, Ishiguchi T, Matsuda J, et al. Human comparative study of zinc and copper excretion via urine after administration of magnetic resonance imaging contrast agents. Radiat Med 2005;23:322-6
16. Emerson J, Kost G. Spurious hypocalcemia after Omniscanor OptiMARK-enhanced magnetic resonance imaging: an algorithm for minimizing a false-positive laboratory value. Arch Pathol Lab Med 2004;128:1151-6
17. Choyke PL. Knopp MV. Pseudohypocalcemia with MR imaging contrast agents: a cautionary tale. Radiology. 2003;227:627-8
18. Lowe A. Balzer T. Hirt U. Interference of gadolinium-containing contrast-enhancing agents with colorimetric calcium laboratory testing. Invest Radiol 2005;40:521-5
19. Wible JH Jr, Hynes MR. Measurement of serum calcium concentration after administration of gadoversetamide in dogs. Radiology 2004;233:158-64
20. Yuh WTC, Engelken JD, Muhoene MG et al. Experience with high-dose gadolinium MR imaging in the evaluation of brain metastases. Am J Neuroradiol 1992;13:335-45