Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

This study has been terminated.
(Changed focus of the program)
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01092546
First received: March 23, 2010
Last updated: November 20, 2013
Last verified: November 2013

March 23, 2010
November 20, 2013
March 2010
April 2011   (final data collection date for primary outcome measure)
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. [ Time Frame: Post flutemetamol Injection ] [ Designated as safety issue: No ]
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 obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.
Brain uptake of [18F]flutemetamol [ Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events (AEs). ] [ Designated as safety issue: No ]
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 obtained during shunt placement in patients who have NPH. The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.
Complete list of historical versions of study NCT01092546 on ClinicalTrials.gov Archive Site
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. [ Time Frame: Post flutemetamol administration ] [ Designated as safety issue: No ]
The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.
Level of association between SUVR and the quantitative estimates of amyloid levels [ Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events (AEs). ] [ Designated as safety issue: No ]
To determine the level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions:Biopsy site and contralateral to the biopsy site.
Not Provided
Not Provided
 
Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NPH) Subjects.

To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Normal Pressure Hydrocephalus
Drug: [18F]Flutemetamol
All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
Other Names:
  • Flutemetamol
  • AH110690
Experimental: Arm 1
Intervention: Drug: [18F]Flutemetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject is at least 50 years of age.
  • The subjects' general health is adequate to comply with study procedures.
  • The subject has been scheduled for a shunt placement procedure for the treatment of NPH.

Exclusion Criteria:

  • The subject has a contraindication for MRI or PET.
  • The subject is pregnant or lactating.
  • The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
  • The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092546
GE-067-009
Yes
GE Healthcare
GE Healthcare
i3 Statprobe
Study Director: Kim A Mansfield, MS GE Healthcare
GE Healthcare
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP