Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

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. Identifier: NCT00999596
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : May 2, 2012
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
Philips Healthcare

Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Breast Cancer

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was initiated at out primary Diagnostic site in April 2010 and concluded in February 2011. A total of 35 diagnostic cases were obtained. Recruitment was initiated at out primary Screening site in May 2010 and concluded in November 2011. A total of 67 screening cases were obtained.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial was to evaluate performance of a FFDM system. During image acquisition FDA modified the trial criteria from an efficacy trial to a SE trial. Images from our diag site prior to Nov could not be used in this study as mag views were now required. Mag views were acquired in Jan-Feb 2011. Selected images were used from our screen site.

Reporting Groups
FFDM (Full Field Digital Mammography) Mammograms from the Philips Digital System

Participant Flow:   Overall Study
    FFDM (Full Field Digital Mammography)
STARTED   107 
New FDA Guideline Released   6 [1] 
COMPLETED   6 [2] 
Statistical population not required                101 
[1] FDA Guidance: Class II Special Controls Guidance Document: Full-Field Digital Mammography System
[2] Not all patient images were used for the reader evaluation based on new FDA Guidelines

  Baseline Characteristics

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.
No text entered.

Reporting Groups
FFDM (Full Field Digital Mammography) Mammograms from the Philips Digital System

Baseline Measures
   FFDM (Full Field Digital Mammography) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   107 
>=65 years   0 
[Units: Participants]
Female   107 
Male   0 
Region of Enrollment 
[Units: Participants]
United States   104 
Germany   3 

  Outcome Measures

1.  Primary:   FFDM (Full Field Digital Mammography) Mammogram Scores   [ Time Frame: Day 1 ]

  Serious Adverse Events

  Other Adverse Events

  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
Change in requirements from FDA modified the reading study per the Nov 5, 2010 FDA Guideline for FFDM.

  More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Sarah Baxter or Linda Jalbert
Organization: Philips Healthcare
phone: 425-487-7665 / 978-659-7434

Responsible Party: Philips Healthcare Identifier: NCT00999596     History of Changes
Other Study ID Numbers: PMSDR-2008-002 & 2010-002
First Submitted: October 21, 2009
First Posted: October 22, 2009
Results First Submitted: June 14, 2011
Results First Posted: May 2, 2012
Last Update Posted: December 4, 2012