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

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