Evaluation of PET Scan Timing Relative to AV-45 Injection Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01565356
First received: March 26, 2012
Last updated: May 3, 2012
Last verified: May 2012
Results First Received: April 6, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir F 18

  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 SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subject Scans 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03

Participant Flow:   Overall Study
    All Subject Scans  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
All Subject Scans 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03

Baseline Measures
    All Subject Scans  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean ± Standard Deviation
  65.49  ± 15.302  
Gender  
[units: participants]
 
Female     14  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures
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1.  Primary:   Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation   [ Time Frame: Scans acquired 30-40 min and 50-60 min after injection ]

2.  Secondary:   Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation   [ Time Frame: Scans acquired 30-40 min and 50-60 min post-injection ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565356     History of Changes
Other Study ID Numbers: 18F-AV-45-A06
Study First Received: March 26, 2012
Results First Received: April 6, 2012
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration