Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).
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Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). / Herborn, Christoph U; Honold, Elmar; Wolf, Michael; Kemper, Jörn; Kinner, Sonja; Adam, Gerhard; Barkhausen, Jörg.
In: INVEST RADIOL, Vol. 42, No. 1, 1, 2007, p. 58-62.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).
AU - Herborn, Christoph U
AU - Honold, Elmar
AU - Wolf, Michael
AU - Kemper, Jörn
AU - Kinner, Sonja
AU - Adam, Gerhard
AU - Barkhausen, Jörg
PY - 2007
Y1 - 2007
N2 - OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
AB - OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
M3 - SCORING: Zeitschriftenaufsatz
VL - 42
SP - 58
EP - 62
JO - INVEST RADIOL
JF - INVEST RADIOL
SN - 0020-9996
IS - 1
M1 - 1
ER -