PHASE IV, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSSOVER STUDY TO COMPARE 0.1 mmol/kg OF MULTIHANCE WITH 0.1 mmol/kg OF GADOVIST IN MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN (MERIT) - MERIT

BRACCO IMAGING0 个研究点目标入组 150 人开始时间: 2009年8月10日最近更新: 2012年4月3日

适应症

试验速览

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•Subjects who have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by: clinical/neurological symptomatology; diagnostic testing, such as CT or previous MRI examinations; or have had recent surgery within 6 months and are to be evaluated for recurrence.
•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

•Subjects who: Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2 Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product. Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min. Have been previously entered into this study Have received or are scheduled for one of the following: Surgery within three weeks prior to the first examination or between the two examinations Initiation of steroid therapy between the two examinations Radiosurgery between the two examinations

发起方

BRACCO IMAGING