A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NPH) Subjects.

GE Healthcare1 site in 1 country12 target enrollmentMarch 2010

ConditionsNormal Pressure Hydrocephalus

Interventions[18F]Flutemetamol

Drugs[18F]Flutemetamol

Overview

Phase: Phase 3
Intervention: [18F]Flutemetamol
Conditions: Normal Pressure Hydrocephalus
Sponsor: GE Healthcare
Enrollment: 12
Locations: 1
Primary Endpoint: Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

April 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Arm 1

Intervention: [18F]Flutemetamol

Outcomes

Primary Outcomes

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

Time Frame: Post flutemetamol Injection

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.