Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Phase 3TerminatedNCT01092546

GE Healthcare12 enrolled

Overview

To determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Normal Pressure Hydrocephalus

Interventions

[18F]FlutemetamolDRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject is at least 50 years of age. * The subjects' general health is adequate to comply with study procedures. * The subject has been scheduled for a shunt placement procedure for the treatment of NPH. Exclusion Criteria: * The subject has a contraindication for MRI or PET. * The subject is pregnant or lactating. * The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients. * 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

Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.

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 shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of \[18F\]flutemetamol (SUVR) will be made from the analysis of PET images.

Time frame: Post flutemetamol Injection

Secondary Outcomes

Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.

The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.

Time frame: Post flutemetamol administration

Data from ClinicalTrials.gov

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