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

October 21, 2009
October 22, 2009
June 14, 2011
May 2, 2012
December 4, 2012
April 2010
January 2011   (Final data collection date for primary outcome measure)
FFDM (Full Field Digital Mammography) Mammogram Scores [ Time Frame: Day 1 ]
6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.
  • ROC Analysis: (ROC) curve based on the radiologists' subjective assessment of the probability that a patient has breast cancer using a continuous scale ranging from 0 (no chance of cancer) to 100 (certainty of cancer). [ Time Frame: 12 months ]
  • For purposes of determining non-inferiority of Philips FFDM to SF, sensitivity and specificity data will be analyzed using a logistic regression model with terms for modality and reader. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00999596 on Archive Site
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  • For ROC and Sensitivity and Specificity, the data will be analyzed using the breast as the basis for the calculation and analysis. [ Time Frame: 12 months ]
  • Adverse Events reported during mammography examinations will be tabulated. [ Time Frame: 1 week ]
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Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography.

Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.

The proposed research study is a prospective enriched reader trial in which patients who meet the study's eligibility criteria, subject to certain constraints specified in this protocol, will undergo both SF and the investigational Philips FFDM mammography. Two to five sites will participate as image acquisition centers. Images will be read by 9 mammographers reading the SF and Philips FFDM acquired images at various locations under the supervision of study managers.

Per the new FDA Guidance document for FFDM (Class II Special Controls Guidance Document: Full-Field Digital Mammography System), there is no longer a requirement for screen film images for a comparison and a reader study to determine accuracy is not required. 10 images acquired under protocols 2008-002a, 2010-002a and a European site will be read in a MQSA type study. This record has been modified to support the new FDA Guidance document.

The reviewers will evaluate the cases, using soft copy and hard copy images, noting the mammographic attributes for each case and documenting the findings on a clinical image evaluation form, which is very similar to what is used for MQSA Accreditation.

The following attributes will be assessed: in order to provide an overall assessment of whether these image sets collectively are of sufficient acceptable quality for mammography:

  • Breast positioning, assessing coverage of the breast on craniocaudal(CC) and medio-lateral oblique (MLO) views, separately;
  • Exposure, assessing visualization of the adipose and fibroglandular tissues and visualization of breast tissue underlying the pectoralis muscle, separately;
  • Breast compression, assessing overlapping breast structures, uniformity of exposure of fibroglandular tissues, adequacy of penetration of thicker portions of the breast, exposure of thinner areas, and motion unsharpness;
  • Image contrast for differentiation of subtle tissue density differences;
  • Sharpness, assessing the edges of fine linear structures and tissues;
  • Borders and benign calcifications;
  • Tissue visibility at the skin line;
  • Noise, i.e., noise obscuring breast structures or suggestive of structures not actually present;
  • Artifacts due to image processing, detector failure and other factors external to the breast on hard-copy and soft-copy displays; and
  • Overall clinical image quality
Time Perspective: Prospective
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Non-Probability Sample
Screening and diagnostic mammography patients
Breast Cancer
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FFDM (Full Field Digital Mammography)
Mammograms from the Philips Digital System
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.
  2. At least 40 years of age
  3. Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
  4. Meets none of the exclusion criteria

Exclusion Criteria:

  1. Presence of a breast implant,
  2. Patients undergoing a unilateral mammogram or an incomplete SF mammogram
  3. had previously undergone an excisional breast biopsy
  4. Pregnant women or patients who believe they may be pregnant

(f) Inmates (in accordance with 45 CFR 46.306)

(g) Patients who cannot, for any reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution

Sexes Eligible for Study: Female
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
PMSDR-2008-002 & 2010-002
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Philips Healthcare
Philips Healthcare
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Study Chair: Linda Jalbert Philips Healthcare
Philips Healthcare
November 2012