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, Jahrgang 42, Nr. 1, 1, 2007, S. 58-62.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

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Vancouver

Herborn CU, Honold E, Wolf M, Kemper J, Kinner S, Adam G et al. Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). INVEST RADIOL. 2007;42(1):58-62. 1.

Bibtex

@article{d8894f22f4be4c7b8669efa928c2f58a,
title = "Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).",
abstract = "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.",
author = "Herborn, {Christoph U} and Elmar Honold and Michael Wolf and J{\"o}rn Kemper and Sonja Kinner and Gerhard Adam and J{\"o}rg Barkhausen",
year = "2007",
language = "Deutsch",
volume = "42",
pages = "58--62",
journal = "INVEST RADIOL",
issn = "0020-9996",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

RIS

TY - JOUR

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 -