Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Phase 3

Terminated

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Drug: [18F]Flutemetamol

• Registration Number: NCT01092546
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-25
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2013-09-05
• Results First Submitted QC: 2013-09-05
• Status Verified: 2013-11
• Results First Posted: 2013-11-19
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	[18F]Flutemetamol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.	Post flutemetamol administration	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.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States