Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01092546
• Other study ID #: GE-067-009
• Status: Terminated
• Phase: Phase 3
• First received: March 23, 2010
• Last updated: November 20, 2013
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: November 2013
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Drug:
• [18F]Flutemetamol
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.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	i3 Statprobe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post flutemetamol Injection	No
Secondary	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.	Post flutemetamol administration	No