A principal, prospective, open-label biopsy study to validate detection of cerebral corticalamyloid with Flutemetamol (18F) Injection in NPH subjects - GE-067-011 Prospective Biopsy [EU]

GE Healthcare Ltd. and its Affiliates0 个研究点目标入组 30 人开始时间: 2010年3月18日最近更新: 2012年3月19日

适应症

试验速览

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•(1) Informed consent has been signed and dated by the subject and/or the subjects’ legally acceptable representative, if applicable, in accordance with local regulations.
•(2) The subject is at least 50 years of age.
•(3) The subjects’ general health is adequate to comply with study procedures.
•(4) The subject has been scheduled for a intracranial pressure measurement or shunt placement procedure for the treatment of NPH.
•(5) For women who are either surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 2 years), enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine human chorionic gonadotropin pregnancy test (with the result known on
•the day of and before the Flutemetamol (18F) Injection administration) must be negative.
•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) The subject has a contraindication for MRI or PET.
•(2) The subject is pregnant or lactating.
•(3) The subject has participated in any clinical study using an investigational agent within 30 days of dosing, with the exception of the PET tracer, 11C-labelled Pittsburgh Compound B ([11C]-PiB).
•(4) The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.

发起方

GE Healthcare Ltd. and its Affiliates