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Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Gustavo Mercier, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00896649
First received: May 9, 2009
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: May 6, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Breast Cancer
Interventions: Other: questionnaire administration
Procedure: digital mammography
Procedure: positron emission 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
193 participants were enrolled onto this study between 4/8/2009 through 5/31/2012 in the Breast Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Arm PEM, Mammography and Questionnaire

questionnaire administration positron emission mammography

digital mammography: standard screening mammogram

questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.

positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram


Participant Flow:   Overall Study
    Single Arm PEM, Mammography and Questionnaire
STARTED   193 
COMPLETED   188 
NOT COMPLETED   5 
Physician Decision                1 
Pregnancy                1 
missing documentation                1 
technical difficulties                2 



  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.
Eligible participants

Reporting Groups
  Description
Positron Emission Mammography (PEM), Mammography, Questionaire

questionnaire administration digital mammography positron emission mammography

questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.

digital mammography: standard screening mammogram

positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram


Baseline Measures
   Positron Emission Mammography (PEM), Mammography, Questionaire 
Overall Participants Analyzed 
[Units: Participants]
 193 
Age [1] 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   182 
>=65 years   11 
[1] Age of the subjects must be greater than or equal to 18 years of age.
Gender, Customized [1] 
[Units: Participants]
 
Female   193 
[1] The gender of the patient must be female per protocol.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
 
Hispanic or Latino   8 
Not Hispanic or Latino   185 
Unknown or Not Reported   0 
[1] Hispanic/Non-Hispanic eligible
Race (NIH/OMB) [1] 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   113 
White   80 
More than one race   0 
Unknown or Not Reported   0 
[1] Caucasian African American
Region of Enrollment [1] 
[Units: Participants]
 
United States   193 
[1] Boston, Massachusetts, USA
Pregnancy status [1] 
[Units: Participants]
 
negative pregnancy status   192 
pregnant status   1 
[1] Only non-pregnant patients are allowed to participate.
No prior history of cancer in previous 5 years 
[Units: Participants]
 193 


  Outcome Measures
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1.  Primary:   Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs BI-RAD "0" in PEM   [ Time Frame: immediately at completion of mammogram ]

2.  Secondary:   Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study   [ Time Frame: One month ]


  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: Gustavo Mercier, House Radiologist
Organization: Boston Medical Center
phone: 617-638-6610
e-mail: gustavo.mercier@bmc.org



Responsible Party: Gustavo Mercier, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00896649     History of Changes
Other Study ID Numbers: CDR0000640404
BUMC-H-27136 ( Other Identifier: BUMC IRB )
W81XWH-06-1-0309 ( Other Identifier: funding number )
05063002 ( Other Identifier )
HRPO #A-13777.2 ( Other Identifier: DoD )
Study First Received: May 9, 2009
Results First Received: May 6, 2016
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration