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Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

Phase 3
40 Years
Not Enrolling
Breast Cancer

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Trial Information

Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

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

- 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

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

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

FFDM (Full Field Digital Mammography) Mammogram Scores

Outcome Description:

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.

Outcome Time Frame:

Day 1

Safety Issue:


Principal Investigator

Linda Jalbert

Investigator Role:

Study Chair

Investigator Affiliation:

Philips Healthcare


United States: Institutional Review Board

Study ID:

PMSDR-2008-002 & 2010-002



Start Date:

April 2010

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Digital Mammography
  • Breast Neoplasms



University of Alabama Birmingham, Alabama  
George Washington Medical Faculty Associates Washington DC, District of Columbia  20037