PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Normal Pressure Hydrocephalus Clinical Trial

Official title:

A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053312
• Other study ID #: GE 067-008
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2010
• Last updated: June 7, 2012
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

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 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).

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	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.	Post-contrast administration	No
Primary	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.	Post-contrast administration	No
Secondary	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.	Post-contrast Administration	No