Assessment of focal liver lesions in fluoroscopic MR using Primovist and fast dynamic imaging sequences for interventional purposes - Liver lesions in fluoroscopic MR

Medical Faculty Magdeburg0 个研究点目标入组 34 人开始时间: 2009年2月27日最近更新: 2012年5月29日

试验速览

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•1.age: between 18 and 85 years
•2.patients with focal liver lesions between 0.5 and 5 cm (reported in previous CT or MR investigations) who are scheduled for biopsy for clinical reasons.
•3.if female, postmenopausal or surgically sterilized
•4.willing and able to undergo all study procedures
•5.having voluntarily provided written and fully informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.coagulation disorder (TPZ < 70%, PTT > 35 sec. , platelets < 100000/ml)
•2.history of severe allergic reaction to MR contrast media or to Primovist (or on of its ingredients)
•3.severe and moderate renal failure (GFR <60 mL as calculated according to the MDRD or Cockroft-Gault formula)
•4.women who are pregnant, lactating or who are of childbearing potential
•5.patients being clinically unstable
•6.uncooperative, in the investigator’s opinion
•7.any contraindication to MR examinations
•8.having been previously enrolled in this study
•9.participating in another clinical trial

发起方

Medical Faculty Magdeburg