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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
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Normal Pressure Hydrocephalus
Intervention: Drug: [18F]Flutemetamol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Started with 16 subjects and 4 withdrew prior to dosing leaving 12 subjects for study.

Reporting Groups
  Description
Arm 1-Flutemetamol Injection [18F]Flutemetamol : All subjects received 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.

Participant Flow:   Overall Study
    Arm 1-Flutemetamol Injection  
STARTED     16  
COMPLETED     12  
NOT COMPLETED     4  
Subjects withdrawn prior to dosing                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
4 of the 16 Subjects were withdrawn prior to study dosing.

Reporting Groups
  Description
Arm 1-Flutemetamol Injection [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.

Baseline Measures
    Arm 1-Flutemetamol Injection  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  71  ± 8.1  
Gender  
[units: participants]
 
Female     5  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.   [ Time Frame: Post flutemetamol administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul Sherwin, M.D.
Organization: GE Healthcare
phone: 609-514-6820
e-mail: Paul.Sherwin@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01092546     History of Changes
Other Study ID Numbers: GE-067-009
Study First Received: March 23, 2010
Results First Received: September 5, 2013
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration