Efficacy and Safety of gadoPIClenol for CenTral NervoUs System (CNS) Magnetic REsonance Imaging (MRI) - The PICTURE trial

Guerbet0 个研究点目标入组 250 人开始时间: 2019年3月5日最近更新: 2020年10月6日

适应症

试验速览

暂无简介。

•- Female or male adult patient (patient having reached legal majority age).
•- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
•- Patient scheduled for a CNS contrast-enhanced MRI examination for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
•- Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
•Some other inclusion criteria are listed in the trial protocol
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Patient presenting extra cranial lesions and/or extra-dural lesions.
•- Patient presenting with an acute relapse of multiple sclerosis as qualifying CNS lesion.
•- Patient presenting with any contraindication to MRI examinations.
•- Patient previously randomized in this trial.
•- Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration.
•Some other exclusion criteria are listed in the trial protocol

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