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PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Primary Purpose

Normal Pressure Hydrocephalus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
[18F] Flutemetamol
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Normal Pressure Hydrocephalus focused on measuring Amyloid, NPH Normal pressure hydrocephalus, PET Positron Emission Tomography, SUVR Standard uptake value ratios

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 flutemetamol

Arm Description

Outcomes

Primary Outcome Measures

Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.
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.
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
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.

Full Information

First Posted
January 19, 2010
Last Updated
June 7, 2012
Sponsor
GE Healthcare
Collaborators
i3 Statprobe
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1. Study Identification

Unique Protocol Identification Number
NCT01053312
Brief Title
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
i3 Statprobe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
Amyloid, NPH Normal pressure hydrocephalus, PET Positron Emission Tomography, SUVR Standard uptake value ratios

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 flutemetamol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F] Flutemetamol
Other Intervention Name(s)
Flutemetamol, AH110690
Intervention Description
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).
Primary Outcome Measure Information:
Title
Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.
Description
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.
Time Frame
Post-contrast administration
Title
Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.
Description
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.
Time Frame
Post-contrast administration
Secondary Outcome Measure Information:
Title
Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Description
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.
Time Frame
Post-contrast Administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim A Mansfield, MS
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

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PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

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