Safety and efficacy of omniscan® (Gadodiamide injection) at 0.1 mmol/kg for MRI in infants younger than 6 months of age: Phase III open multicenter study

Investigative Radiology

Volumn 35, Issue 2, 2000, Pages 141-147

  Martí Bonmatí, Luis ^a   Vega, Teresa ^b   Benito, Carlos ^c   Muñoz, Alberto ^d   Niewel, Manuela ^b   Menor, Francisco ^e   Meurer, Karoline ^f   Encina, Juan Luis ^b  

^a HOSPITAL UNIVERSITARIO DR PESET   (Spain)

^b Nycomed Amersham   (Spain)

^c HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^d HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^e HOSPITAL UNIVERSITARIO LA FE   (Spain)

^f Nycomed Amersham   (Germany)

Author keywords

Contrast media, magnetic resonance; Contrast media, toxicity; Infants, newborns; Magnetic resonance, contrast agents; Magnetic resonance, in infants and children

Indexed keywords

GADODIAMIDE;

ARTICLE; BLOOD ANALYSIS; CLINICAL TRIAL; CONTRAST ENHANCEMENT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART RATE; HUMAN; HUMAN CELL; HUMAN TISSUE; INFANT; INFANT DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEWBORN; NUCLEAR MAGNETIC RESONANCE; OXYGEN SATURATION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PULSE OXIMETRY; URINALYSIS;

EID: 0033983192     PISSN: 00209996     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004424-200002000-00008     Document Type: Article

References (14)

1. Harpur ES, Worah D, Hals P-A, Holtz E, Furuhama K, Nomura H. Preclinical safety assessment and pharmacokinetics of gadodiamide injection, a new magnetic resonance imaging contrast agent. Invest Radiol 1993;28:S28-S43.
2. Van Wagoner M, O'Toole M, Worah D, Leese PT, Quay SC. A phase I clinical trial with gadodiamide injection, a nonionic MR imaging enhancement agent. Invest Radiol 1991;26:980-986.
3. Sze G, Brant-Zawadzki M, McNamara MT, et al. Multicenter study of gadodiamide injection as a contrast enhancing agent in MR imaging of the brain and spine. Radiology 1991;181:693-699.
4. Akeson P, Jonsson E, Haugen I, Holtas S. Contrast-enhanced MRI of the central nervous system: Comparison between gadodiamide injection and gadolinium-DTPA. Neuroradiology 1995;37:229-233.
5. Andrew E, Svaland M, Lundby B, Hugo F, Lafrance N. Clinical experience with gadodiamide injection in magnetic resonance imaging of the central nervous system. Invest Radiol 1994;29:S186-188.
6. Vogl TJ, Mack MG, Juergens M, et al. MR diagnosis of head and neck: Comparison of contrast enhancement with triple-dose gadodiamide and standard-dose gadopentetate dimeglumine in the same patients. AJR 1994;163:425-432.
7. Berg KJ, Lundby B, Reinton V, Nordal KP, Rootwelt K, Smith HJ. Gadodiamide in renal transplant patients: Effects on renal function and usefulness as a glomerular filtration rate marker. Nephron 1994;72:212-217.
8. Kinkel K, Tardivon A, Soyer P, et al. Dynamic contrast-enhanced subtraction versus T2-weighted spin-echo MR imaging in the follow-up of colorectal neoplasm: A prospective study of 41 patients. Radiology 1996;200:453-458.
9. Reuter M, Steffens JC, Schueppler U, et al. Critical evaluation of the specificity of MRI and TVUS for differentiation of malignant from benign adnexal lesions. Eur Radiol 1998;8:39-44.
10. Hanquinet S, Christophe C, De Greef D, Gordon P, Perlmutter N. Clinical evaluation of gadodiamide injection in paediatric MR imaging. Pediatr Radiol 1996;26:806-810.
11. Aslanian V, Lemaignen H, Bunouf P, Svaland MG, Borseth A, Lundby B. Evaluation of the clinical safety of gadodiamide injection, a new nonionic MRI contrast medium for the central nervous system: A European perspective. Neuroradiology 1996;38:537-541.
12. Ekholm S, Jonsson E, Sandvik L, et al. Tolerance and efficacy of Omniscan (gadodiamide injection) in MR imaging of the central nervous system. Acta Radiol 1996;37:223-228.
13. Elderik OP, Brunberg JA. Gadopentetate dimeglumine-enhanced MR of the brain: Clinical utility and safety in patients younger than two years of age. AJNR 1994;15:1001-1008.
14. Taber KH, Hayman LA, Northrup SR, Maturi L. Vital sign change during infant magnetic resonance examination. J Magn Reson Imaging 1998;8:1252-1256.