- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053312
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
June 7, 2012 updated by: GE Healthcare
A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Princeton, New Jersey, United States, 08540
- GE Healthcare
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 flutemetamol
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Post-contrast administration
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Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.
Time Frame: Post-contrast administration
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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.
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Post-contrast administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Time Frame: Post-contrast Administration
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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.
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Post-contrast Administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Kim A Mansfield, MS, GE Healthcare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (Estimate)
January 21, 2010
Study Record Updates
Last Update Posted (Estimate)
June 11, 2012
Last Update Submitted That Met QC Criteria
June 7, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE 067-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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