Patients who have been biopsied during an intracranial procedure 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 had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid. (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 Investigational Medicinal Product (IMP) 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 |
|---|---|
| Primary end point(s): The primary efficacy endpoint will be the SUVR contralateral to and at the approximate level of the biopsy site.;Main Objective: To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative estimates of amyloid levels in biopsy samples (primary standard of truth [SOT]) previously obtained during intracranial pressure measurement in patients who have normal pressure hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (standard uptake value ratios [SUVR]) will be made from the analysis of positron emission tomography (PET) images at a location on the contralateral brain hemisphere that corresponds to the biopsy site.;Secondary Objective: To determine the level of association between SUVR and the quantitative estimates of amyloid levels for the following regions: • Ipsilateral SUVR estimates compared to quantitative estimates of amyloid levels in the biopsy samples – primary SOT • Contralateral SUVR estimates compared to other quantitative estimates of amyloid levels in the biopsy samples – secondary SOT 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 estimates of amyloid levels in the biopsy samples. To determine the level of association between SUVR values determined from (18F]flutemetamol PET images and those determined from PET images made using 11C-labelled Pittsburgh Compound B ([11C]-PiB), in subjects who have undergone, or who will undergo, [11C]-PiB imaging independent of this study. | — |
Countries
Finland
Outcome results
None listed