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Toward an Automated Method of Abdominal Fat Segmentation of MR Images

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01228968
First received: October 25, 2010
Last updated: May 11, 2011
Last verified: May 2011
Results First Received: April 11, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: Obesity

  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
we recruited subjects currently enrolled in related 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
Volunteers Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.

Participant Flow:   Overall Study
    Volunteers  
STARTED     9  
COMPLETED     9  
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
Volunteers Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.

Baseline Measures
    Volunteers  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  39.8  ± 9.3  
Gender  
[units: participants]
 
Female     8  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures
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1.  Primary:   Visceral Fat Volume With Automated Analysis   [ Time Frame: five minutes ]

2.  Primary:   Visceral Fat Volume With Manual Segmentation   [ Time Frame: five minutes ]

3.  Secondary:   Subcutaneous Fat Volume With Automated Analysis   [ Time Frame: five minutes ]

4.  Secondary:   Subcutaneous Fat Volume With Manual Segmentation   [ Time Frame: five minutes ]


  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 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: Gary Skolnick
Organization: Washington University School of Medicine
phone: 3143625292
e-mail: gskolnic@wustl.edu


No publications provided


Responsible Party: Samuel Klein, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01228968     History of Changes
Other Study ID Numbers: MRImethods060229
Study First Received: October 25, 2010
Results First Received: April 11, 2011
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board