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Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106911
First Posted: April 20, 2010
Last Update Posted: March 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jules Sumkin, University of Pittsburgh
Results First Submitted: January 25, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Breast Abnormalities
Intervention: Device: tomosynthesis and screening mammography

  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
Subjects were consented, screened and enrolled at one site, a medical hospital specializing in women's health. The period of recruitment was from May, 2010 to September, 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three subjects were deemed ineligible. Two subjects were withdrawn by the PI after beginning research procedures.

Reporting Groups
  Description
Digital Breast Tomosynthesis (DBT) Consented and eligible women undergoing baseline screening mammography received DBT

Participant Flow:   Overall Study
    Digital Breast Tomosynthesis (DBT)
STARTED   1085 
COMPLETED   1080 
NOT COMPLETED   5 
Physician Decision                2 
deemed ineligible after screening                3 



  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.
Participants who completed research procedures

Reporting Groups
  Description
Digital Breast Tomosynthesis (DBT) Consented and eligible women undergoing baseline screening mammography received DBT

Baseline Measures
   Digital Breast Tomosynthesis (DBT) 
Overall Participants Analyzed 
[Units: Participants]
 1080 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.03  (3.75) 
Gender 
[Units: Participants]
 
Female   1080 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   10 
Not Hispanic or Latino   1054 
Unknown or Not Reported   16 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   35 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   278 
White   751 
More than one race   0 
Unknown or Not Reported   16 
Region of Enrollment 
[Units: Participants]
 
United States   1080 


  Outcome Measures

1.  Primary:   Number of Participants Without Cancer Who Were Recalled   [ Time Frame: upon recruitment/enrollment phase completion ]


  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: Dr. Jules H. Sumkin
Organization: University of Pittsburgh
phone: 412-641-1976
e-mail: jsumkin@upmc.edu



Responsible Party: Jules Sumkin, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01106911     History of Changes
Other Study ID Numbers: PRO09060334
First Submitted: April 16, 2010
First Posted: April 20, 2010
Results First Submitted: January 25, 2016
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016