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PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01053312
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : June 5, 2012
Last Update Posted : June 11, 2012
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Drug: [18F] Flutemetamol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.


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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053312


Locations
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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
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Study Director: Kim A Mansfield, MS GE Healthcare
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01053312    
Other Study ID Numbers: GE 067-008
First Posted: January 21, 2010    Key Record Dates
Results First Posted: June 5, 2012
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by GE Healthcare:
Amyloid
NPH Normal pressure hydrocephalus
PET Positron Emission Tomography
SUVR Standard uptake value ratios
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action