Breast Cancer
Conditions
Keywords
Breast Cancer, Digital Mammography
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
Philips Healthcare
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFDM (Full Field Digital Mammography) Mammogram Scores | 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. |
Countries
Germany, United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| FFDM (Full Field Digital Mammography) Mammograms from the Philips Digital System | 107 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Statistical population not required | 101 |
Baseline characteristics
| Characteristic | FFDM (Full Field Digital Mammography) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Region of Enrollment Germany | 3 participants |
| Region of Enrollment United States | 104 participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
FFDM (Full Field Digital Mammography) Mammogram Scores
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.
Time frame: Day 1
Population: This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FFDM Mammograms Score = Pass | FFDM (Full Field Digital Mammography) Mammogram Scores | 12 FFDM Mammogram set |
| FFDM Mammograms Score = Fail | FFDM (Full Field Digital Mammography) Mammogram Scores | 0 FFDM Mammogram set |