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PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

This study has been completed.
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: January 19, 2010
Last updated: June 7, 2012
Last verified: June 2012
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).

Condition Intervention Phase
Normal Pressure Hydrocephalus
Drug: [18F] Flutemetamol
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. [ Time Frame: Post-contrast administration ]
    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.

  • Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. [ Time Frame: Post-contrast administration ]
    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.

Secondary Outcome Measures:
  • Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects [ Time Frame: Post-contrast Administration ]
    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.

Enrollment: 7
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 flutemetamol 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).
Other Names:
  • Flutemetamol
  • AH110690


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01053312

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Study Director: Kim A Mansfield, MS GE Healthcare
  More Information

Responsible Party: GE Healthcare Identifier: NCT01053312     History of Changes
Other Study ID Numbers: GE 067-008
Study First Received: January 19, 2010
Results First Received: March 28, 2012
Last Updated: June 7, 2012

Keywords provided by GE Healthcare:
NPH Normal pressure hydrocephalus
PET Positron Emission Tomography
SUVR Standard uptake value ratios

Additional relevant MeSH terms:
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 28, 2017