Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Mahoney, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00981812
First received: September 18, 2009
Last updated: March 3, 2016
Last verified: March 2016
Results First Received: December 23, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Breast Cancer
Intervention: Procedure: PEM Breast Biopsy

  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
Recruited from 02/2010 to 06/2011 from University of Cincinnati Medical Center, Radiology Department, Breast Imaging.

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
PEM Breast Biopsy PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software

Participant Flow:   Overall Study
    PEM Breast Biopsy  
STARTED     20  
COMPLETED     20  
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.
Women 25 or older

Reporting Groups
  Description
Primary Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.

Baseline Measures
    Primary  
Number of Participants  
[units: participants]
  20  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     3  
Gender  
[units: participants]
 
Female     20  
Male     0  
[1] Women 25 years of age or older with a highly suspicious breast mass recommended to biopsy.



  Outcome Measures

1.  Primary:   Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.   [ Time Frame: At time of biopsy ]


  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: Mary Mahoney, MD
Organization: University of Cincinnati Medical Center
phone: 513-584-4396
e-mail: mary.mahoney@uchealth.com



Responsible Party: Mary Mahoney, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00981812     History of Changes
Other Study ID Numbers: Cincinnati-01
Study First Received: September 18, 2009
Results First Received: December 23, 2014
Last Updated: March 3, 2016
Health Authority: United States: Institutional Review Board