EUCTR2010-018715-15-FI
Active, not recruiting
Not Applicable
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 sites30 target enrollmentMarch 18, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subjects who are scheduled for intracranial pressure measurement or intracranial shunt placement due to suspected Normal Pressure Hydrocephalus (NPH)
- Sponsor
- GE Healthcare Ltd. and its Affiliates
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified
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