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Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities (PEM-BX)

This study has been completed.
Sponsor:
Collaborators:
American Radiology Services, Inc
Boca Raton community Hospital, FL
Diversified Specialty Institutes, Bensalem, PA
Advanced Breast Care Imaging
Epic Imaging
Information provided by:
Naviscan PET Systems
ClinicalTrials.gov Identifier:
NCT00606931
First received: January 22, 2008
Last updated: May 20, 2009
Last verified: May 2009
History of Changes
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Breast Cancer
Intervention: Device: Stereo Navigator Accessory to PEM Flex PET Scanner

  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
Patients were recruited between January & July 2008 at the medical center where they underwent PEM imaging.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first enrolled participant was excluded from the analysis, the subject signed the consent form prior to the trial being officially released.

Reporting Groups
  Description
PET Guided Biopsy No comparison group. All enrolled participants were expected to undergo PET guided biopsy.

Participant Flow:   Overall Study
    PET Guided Biopsy  
STARTED     22  
COMPLETED     19  
NOT COMPLETED     3  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Reporting Groups
  Description
PET Guided Biopsy No comparison group. All enrolled participants were expected to undergo PET guided biopsy.

Baseline Measures
    PET Guided Biopsy  
Number of Participants  
[units: participants]
 		  22  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation 		  58.5  ± 11.9  
Gender  
[units: participants]
 		 
Female     22  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     22  



  Outcome Measures
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1.  Primary:   Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.   [ Time Frame: within two days of obtaining histopathology of the lesion biopsied ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy   [ Time Frame: Within one week of completing PET-guided biopsy ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Number of Participants Who Tolerated the PET-Guided Biopsy Procedure   [ Time Frame: Within one week of completing PET-guided biopsy ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Judith E Kalinyak, MD, PhD, Medical Director
Organization: Naviscan Inc
phone: 858-587-3641 ext 108
e-mail: jkalinyak@naviscan.com


No publications provided by Naviscan PET Systems

Publications automatically indexed to this study:


Responsible Party: Judith Kalinyak, MD. Ph.D, Medical Director, Naviscan PET Systems, Inc
ClinicalTrials.gov Identifier: NCT00606931     History of Changes
Other Study ID Numbers: PEM-07-02, NIH/NCI 5 R44 CA082042-03
Study First Received: January 22, 2008
Results First Received: March 27, 2009
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board