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PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01053312
First received: January 19, 2010
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053312

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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on June 13, 2013