Subjects who are scheduled for intracranial pressure measurement or intracranial shunt placement due to suspected Normal Pressure Hydrocephalus (NPH) MedDRA version: 12.1 Level: LLT Classification code 10029773 Term: Normal pressure hydrocephalus
Conditions
Sponsors
GE Healthcare Ltd. and its Affiliates
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during intracranial pressure measurement or shunt placement in patients who have suspected normal pressure hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (standard uptake value ratios [SUVR]) from the biopsy site will be made from the analysis of positron emission tomography (PET) images. The quantitative immunohistochemical estimates of amyloid levels will be estimated for each biopsy sample obtained at the site of the biopsy using a monoclonal antibody, NAB228, raised against amyloid – primary standard of truth (SOT).;Secondary Objective: To determine the level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the studied regions. To determine the levels of association between the blinded visual assessment of PET images (normal/abnormal amyloid levels) and the assessment of normal and abnormal amyloid levels from the quantitative histochemical/immunohistochemical estimates of amyloid levels in the biopsy samples.;Primary end point(s): The primary endpoint will be the SUVR at the site of the biopsy. | — |
Countries
Finland
Outcome results
None listed