PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

GE Healthcare7 enrolled

Overview

This study will 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 previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Normal Pressure Hydrocephalus

Interventions

[18F] FlutemetamolDRUG

All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject is 50 years old or older. * The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid. * Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations. Exclusion Criteria: * The subject has a contraindication for MRI or PET. * The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol. * The subject has participated in any clinical study using an investigational agent within 30 days of dosing.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.

Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\_voi/SUV\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\_voi) or reference region (SUV\_ref). VOI means volume of interest and REF means reference region.

Time frame: Post-contrast administration

Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.

This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.

Time frame: Post-contrast administration

Secondary Outcomes

Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects

Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \[18F\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.

Time frame: Post-contrast Administration

Data from ClinicalTrials.gov

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