A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied
Overview
- Phase
- Phase 3
- Intervention
- [18F] Flutemetamol
- Conditions
- Normal Pressure Hydrocephalus
- Sponsor
- GE Healthcare
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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).
Investigators
Eligibility 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.
Arms & Interventions
1 flutemetamol
Intervention: [18F] Flutemetamol
Outcomes
Primary Outcomes
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 Outcomes
- Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects(Post-contrast Administration)