Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01011946
First received: November 10, 2009
Last updated: June 16, 2015
Last verified: June 2015
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Breast Cancer
Intervention: Device: 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
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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
Positron Emission Mammography Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).

Participant Flow:   Overall Study
    Positron Emission Mammography  
STARTED     36  
COMPLETED     33  
NOT COMPLETED     3  
Transferred to another hospital                 2  
No pathological lab value                 1  



  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.
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Reporting Groups
  Description
Positron Emission Mammography Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).

Baseline Measures
    Positron Emission Mammography  
Number of Participants  
[units: participants]
  36  
Age  
[units: years]
Mean (Standard Deviation)
  57.4  (10.9)  
Gender  
[units: participants]
 
Female     36  
Male     0  



  Outcome Measures

1.  Primary:   Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer   [ Time Frame: PEM was performed prior to surgery and LN sampling immediately following surgery ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Appelbaum
Organization: University of Chicago
phone: (773) 834-2012
e-mail: dappelbaum@radiology.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01011946     History of Changes
Other Study ID Numbers: 16893A
Study First Received: November 10, 2009
Results First Received: June 1, 2015
Last Updated: June 16, 2015
Health Authority: United States: Food and Drug Administration